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Alcazar JL, Peñate L, Casanova V, Piera C, Engels V, Medina M, Ros C, Sotillo L, Antolín E, Pelayo I, Bermejo C, Pascual MÁ, Graupera B, Barreche I, Orozco R, Ajossa S, Guerriero S. Prevalence of contrast intravasation in HyCoSy/HyFoSy. Results of a multicenter study and systematic review of the literature with meta-analysis. Eur J Obstet Gynecol Reprod Biol 2025; 305:100-106. [PMID: 39673914 DOI: 10.1016/j.ejogrb.2024.12.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2024] [Revised: 11/30/2024] [Accepted: 12/08/2024] [Indexed: 12/16/2024]
Abstract
OBJECTIVE To determine the frequency of uterine contrast agent intravasation during HyCoSy/HyFoSy for assessing tubal patency in infertile women. METHODS Prospective observational multicenter study performed in nine European university hospitals, comprising a series of non-consecutive women who underwent HyFoSy (ExEmTM foam) for tubal patency assessment in the context of infertility between May 2016 and December 2022. All examinations were performed using the same scanning protocol. In addition, a systematic review of literature using database search (Pubmed, Scopus and Web of Science) of articles published between January 2000 and March 2024 evaluating the presence of venous contrast intravasation during HyCoSy/HyFoSy for assessment of tubal patency in infertile women. Pooled prevalence for intravasation was estimated. Heterogeneity was assessed by calculating I2. Quality of studies was assessed using the Newcastle-Ottawa scale. RESULTS Prospective study: 1946 women were recruited. Intravasation was observed in 12 cases (0.6 %, 95 % CI: 0.5 %-0.9 %). The frequency of intravasation was similar in seven centers, ranging from 0 % to 0.7 %. In two centers the frequency observed was higher, 2.6 % and 3.0 %, respectively. No significant patient reaction or complication was observed in those 12 women with intravasation. In addition, the search identified 74 studies. After exclusions, 11 articles (9 using SonoVueTM and 2 using ExEmTM foam) were included, comprising data from 5028 women. Pooled prevalence for contrast intravasation was significantly higher for SonoVueTM (23.0 %, 95 %CI: 19.0 %-27.0 %) than for ExEmFoam (7.0 %, 95 %CI: 5.0 %-9.0 %). Heterogeneity was high (I2: 91.8 %). Studies quality was good. CONCLUSION Uterine intravasation is less frequent using ExEmTM foam than SonoVueTM.
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Affiliation(s)
- Juan Luis Alcazar
- Department of Obstetrics and Gynecology, Hospital QuirónSalud, Málaga, Spain; Faculty of Medicine, University of Navarra, Pamplona, Spain.
| | - Laura Peñate
- Department of Obstetrics and Gynecology, Torrejon University Hospital, Torrejon de Ardoz, Spain
| | - Virgina Casanova
- Department of Obstetrics and Gynecology, Hospital Virgen de la Luz, Cuenca, Spain
| | - Clara Piera
- Department of Obstetrics and Gynecology, Hospital Denia, Denia, Spain
| | - Virginia Engels
- Division of Maternal and Fetal Medicine, Department of Obstetrics and Gynecology, Hospital Universitario La Paz. IdiPAZ Madrid, Spain
| | - Margarita Medina
- Department of Obstetrics and Gynecology, Hospital Universitario Materno-Infantil, Las Palmas de Gran Canaria, Spain
| | - Cristina Ros
- Department of Gynecology, Institut Clínic de Ginecologia, Obstetrícia, i Neonatologia, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain
| | - Laura Sotillo
- Division of Maternal and Fetal Medicine, Department of Obstetrics and Gynecology, Hospital Universitario La Paz. IdiPAZ Madrid, Spain
| | - Eugenia Antolín
- Division of Maternal and Fetal Medicine, Department of Obstetrics and Gynecology, Hospital Universitario La Paz. IdiPAZ Madrid, Spain
| | - Irene Pelayo
- Department of Obstetrics and Gynecology, Hospital Universitario Ramón y Cajal, Alcala de Henares University, Madrid, Spain
| | | | - María Ángela Pascual
- Department of Obstetrics, Gynecology, and Reproduction, Hospital Universitari Dexeus, Barcelona, Spain
| | - Betlem Graupera
- Department of Obstetrics, Gynecology, and Reproduction, Hospital Universitari Dexeus, Barcelona, Spain
| | - Irene Barreche
- Department of Obstetrics and Gynecology, Hospital QuirónSalud, Málaga, Spain
| | - Rodrigo Orozco
- Department of Obstetrics and Gynecology, Hospital QuirónSalud, Málaga, Spain
| | - Silvia Ajossa
- Centro Integrato di Procreazione Medicalmente Assistita (PMA) e Diagnostica Ostetrico-Ginecologica, Policlinico Universitario Duilio Casula, Monserrato, University of Cagliari, Cagliari, Italy
| | - Stefano Guerriero
- Centro Integrato di Procreazione Medicalmente Assistita (PMA) e Diagnostica Ostetrico-Ginecologica, Policlinico Universitario Duilio Casula, Monserrato, University of Cagliari, Cagliari, Italy
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Le MT, Vo BH, Le HP, Pham AP, Vu AL, Pham TD, Truong TT, Ho TM, Dang VQ. Diagnostic accuracy of hysterosalpingo-foam sonography for assessment of fallopian tube patency in infertile women. Reprod Biomed Online 2024; 49:104112. [PMID: 39013260 DOI: 10.1016/j.rbmo.2024.104112] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2024] [Revised: 05/09/2024] [Accepted: 05/09/2024] [Indexed: 07/18/2024]
Abstract
RESEARCH QUESTION What is the diagnostic accuracy of hysterosalpingo-foam sonography (HyFoSy), using two-dimensional ultrasound in tubal patency assessment in infertile women compared with laparoscopy with dye chromotubation? DESIGN This prospective study was conducted at My Duc Hospital, Vietnam. Infertile women aged 18 years or older, who were scheduled for laparoscopy, were included. Visual Analogue Scale (VAS) score for perception of pain during HyFoSy was used. Laparoscopy was carried out on the same day. Clinicians undertaking laparoscopy were blinded to HyFoSy results. Sensitivity, specificity, negative and positive predictive value, and 95% confidence intervals were calculated. A sample size of 455 women (n = 910 fallopian tubes) was needed to demonstrate a fluctuation hypothesis, not exceeding 6%, for sensitivity and specificity (power 0.80, two-sided alpha 5%, loss to follow-up 5%). RESULTS Between 2019 and 2022, 455 participants were recruited. Hysterosalpingo-foam sonography was unsuccessfully carried out in six participants. Two withdrew their consent. Data analysis was conducted on the remaining 447 participants (n = 868 fallopian tubes). The sensitivity and specificity of hysterosalpingo-foam sonography compared with laparoscopy were 0.75 (95% CI 0.71 to 0.79) and 0.70 (95% CI 0.65 to 0.74), respectively. Hysterosalpingo-foam sonography gave a positive predictive value of 0.76 (95% CI 0.73 to 0.80) and negative predictive value of 0.68 (95% CI 0.64 to 0.73). A total of 42.8% of women reported a VAS score of no pain. No adverse event was reported. CONCLUSION Compared with laparoscopy with dye chromotubation, two-dimensional HyFoSy is a well-tolerated, reliable technique for assessing tubal patency.
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Affiliation(s)
- My T Le
- Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam.
| | - Binh H Vo
- Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam
| | - Hoa P Le
- Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam
| | - Anh P Pham
- Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam
| | - Anh L Vu
- HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam
| | - Toan D Pham
- HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam
| | - Tham T Truong
- Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam
| | - Tuong M Ho
- Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam
| | - Vinh Q Dang
- HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam; Department of Obstetrics and Gynaecology, School of Clinical Science, Monash University, Melbourne, Australia
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3
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Ford J, Hince D, Lee E, Lo G. Intravasation complicating hysterosalpingo-foam sonography (HyFoSy) using ExEm® Foam. Aust N Z J Obstet Gynaecol 2023; 63:577-582. [PMID: 37185818 DOI: 10.1111/ajo.13682] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2022] [Accepted: 03/26/2023] [Indexed: 05/17/2023]
Abstract
BACKGROUND Transvaginal hysterosalpingo-foam sonography (HyFoSy) assesses tubal patency in an outpatient setting and without ionising radiation, unlike traditional hysterosalpingography (HSG) under fluoroscopy. Like HSG, HyFoSy may be complicated by uterine intramural contrast leak, leading to venous intravasation. Intravasation of particulate contrast agents risks pulmonary or cerebral emboli. AIMS We aimed to assess the intravasation rate of HyFoSy using ExEm® Foam and association with endometrial thickness, ExEm® Foam volume, uterine length, adenomyosis severity, uterine morphology or pain score. METHODS An ethics-approved retrospective study on all HyFoSy examinations between 23 January 2018 and 27 October 2021 on sub-fertile patients, trying to conceive. Initial transvaginal sonography confirmed anatomy, uterine morphology, adenomyosis severity and endometrial thickness. Subspecialist radiologists performed HyFoSy with sonographer assistance. Intravasation was identified in real time but also checked for afterwards. Patients were asked to rate instillation pain/discomfort from one to ten immediately afterward. RESULTS Four hundred and thirty-six (n = 436) patients met inclusion criteria. Thirty (6.9%) experienced intravasation. Endometrial thickness and pain score were associated with intravasation. For every millimetre increase in endometrial thickness, the odds of intravasation decreased by 26% (P = 0.010). For every point increase on the pain scale, the odds of intravasation increased by 22% (P = 0.032). There was no evidence of an association between instilled ExEm® Foam volume or the other previously published parameters with intravasation. CONCLUSION A 6.9% rate of intravasation was observed. Both endometrial thickness and pain score were significantly associated with intravasation. There was no evidence of an association between ExEm® Foam volume and intravasation.
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Affiliation(s)
- Jemma Ford
- Western Ultrasound For Women, Perth, Western Australia, Australia
- Sir Charles Gairdner Osborne Park Hospital Care Group, Perth, Western Australia, Australia
| | - Dana Hince
- Institute for Health Research, The University of Notre Dame, Fremantle, Western Australia, Australia
| | - Emmeline Lee
- Western Ultrasound For Women, Perth, Western Australia, Australia
- Sir Charles Gairdner Osborne Park Hospital Care Group, Perth, Western Australia, Australia
| | - Glen Lo
- Western Ultrasound For Women, Perth, Western Australia, Australia
- Sir Charles Gairdner Osborne Park Hospital Care Group, Perth, Western Australia, Australia
- Curtin University Medical School, Perth, Western Australia, Australia
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Caproni M, Calabria VRD, Mariotti EB, Verdelli A, Aimo C, Corrà A, Quintarelli L, Volpi W, Alpsoy E, Sunderkötter C. The impact on the scientific community of the 2018 addendum to the CHCC. Front Med (Lausanne) 2022; 9:1081063. [DOI: 10.3389/fmed.2022.1081063] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2022] [Accepted: 11/02/2022] [Indexed: 12/02/2022] Open
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Devine K, Dolitsky S, Ludwin I, Ludwin A. Modern assessment of the uterine cavity and fallopian tubes in the era of high-efficacy assisted reproductive technology. Fertil Steril 2022; 118:19-28. [PMID: 35725118 DOI: 10.1016/j.fertnstert.2022.05.020] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2022] [Revised: 05/12/2022] [Accepted: 05/12/2022] [Indexed: 11/28/2022]
Abstract
The high efficacy of modern assisted reproductive technology (ART) and increase in the number of noninfertile patients who are using ART for family building in the United States call into question the relevance of the standard, one-size-fits-all infertility evaluation. Here, we explore whether all patients presenting for ART need uterine cavity and tubal assessment and what tests are most appropriate, efficient, and cost-effective in current times.
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Affiliation(s)
- Kate Devine
- Division of Reproductive Endocrinology and Infertility, Program in Reproductive and Adult Endocrinology, Eunice Kennedy Shriver NICHD, National Institutes of Health, Bethesda, Maryland; Shady Grove Fertility, Washington, D.C..
| | - Shelley Dolitsky
- Division of Reproductive Endocrinology and Infertility, Program in Reproductive and Adult Endocrinology, Eunice Kennedy Shriver NICHD, National Institutes of Health, Bethesda, Maryland
| | - Inga Ludwin
- Department of Gynecology and Oncology, Jagiellonian University, Krakow, Poland; Ludwin & Ludwin Gynecology, Private Medical Center, Krakow, Poland
| | - Artur Ludwin
- Department of Gynecology and Oncology, Jagiellonian University, Krakow, Poland; Ludwin & Ludwin Gynecology, Private Medical Center, Krakow, Poland
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Tros R, Rosielle K, Koks C, Mijatovic V, Bongers MY, Mol BWJ, Wang R. Visual tubal patency tests for tubal occlusion and hydrosalpinx. Hippokratia 2022. [DOI: 10.1002/14651858.cd014968] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Affiliation(s)
- Rachel Tros
- Department of Obstetrics and Gynaecology; Amsterdam UMC, VU Universiteit Amsterdam, De Boelelaan 1117; Amsterdam Netherlands
| | - Kimmy Rosielle
- Department of Obstetrics and Gynaecology; Amsterdam UMC, VU Universiteit Amsterdam, De Boelelaan 1117; Amsterdam Netherlands
| | - Carolien Koks
- Department of Reproductive Medicine; Máxima MC; Eindhoven Netherlands
| | - Velja Mijatovic
- Academic Endometriosis Center, Department of Reproductive Medicine; Amsterdam UMC; Amsterdam Netherlands
| | - Marlies Y Bongers
- Department of Obstetrics and Gynaecology; Máxima Medisch Centrum; Veldhoven Netherlands
| | - Ben Willem J Mol
- Department of Obstetrics and Gynaecology; Monash University; Clayton Australia
| | - Rui Wang
- Department of Obstetrics and Gynaecology; Monash University; Clayton Australia
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Zhang Y, Zhu Y, Ge B, Sui M, Zheng Z, Sun J. Reproductive outcome of hysteroscopic metroplasty for women with T-shaped uterus: a retrospective study. Reprod Health 2022; 19:78. [PMID: 35346261 PMCID: PMC8962238 DOI: 10.1186/s12978-022-01381-2] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/16/2021] [Accepted: 03/09/2022] [Indexed: 11/18/2022] Open
Abstract
Background T-shaped uterus is a Müllerian malformation with unapparent clinical manifestations. Intrauterine adhesion and tuberculosis may lead to T-shaped uterus, too. Hysteroscopic metroplasty is a treatment option for T-shaped uterus, while the postoperative reproductive outcomes have not been thoroughly investigated. The aim of this study was to determine the reproductive outcome in Chinese women with T-shaped uterus who had hysteroscopic metroplasty with cold scissors. Methods This retrospective cohort study was conducted in the reproductive surgery unit of a university-affiliated hospital. One hundred and eleven patients with T-shaped uterus who underwent hysteroscopic metroplasty from Jan. 2017 to Sept. 2019 were followed-up by telephone in Apr. 2021. All patients received hysteroscopic metroplasty using microcissors, followed by estrogen-progesterone sequential treatment, with or without intrauterine device (IUD) implantation. According to whether they had had history of intrauterine operation, patients were divided into congenital group and acquired group. The main outcome measure was postoperative live birth rate. χ2 test and t test were used for comparison between groups. Cochran-Mantel–Haenszel test were used for stratified analysis. P < 0.05 was considered statistically significant. Results One hundred and eleven patients were included in total, with 46 in congenital group and 65 in acquired group. After hysteroscopic metroplasty, in the congenital group, the pregnancy rate increased from 28.3% to 87.0% (P < 0.001) and the live birth rate increased from 23.1% to 79.5% (P = 0.001); in the acquired group, the pregnancy rate slightly dropped from 98.5% to 72.3% (P < 0.001) while the live birth rate increased from 20.8% to 74.5% (P < 0.001). No statistically significant difference was observed in postoperative reproductive outcome indicators between the two subgroups except mode of conception. Conclusions For both groups, hysteroscopic metroplasty may improve reproductive outcomes for patients with T-shaped uterus. Supplementary Information The online version contains supplementary material available at 10.1186/s12978-022-01381-2. As a Müllerian malformation, T-shaped uterus is named for the shape of the uterine cavity. According to cause of the disease and patients’ intrauterine operation history, T-shaped uterus can be divided into congenital and acquired types. This study was conducted in the reproductive surgery unit in a university-affiliated hospital. Data were collected from medical records, and patients were followed up via telephone. One hundred and eleven patients were included in this study, with 46 in congenital group and 65 in acquired group. Whether infertility/subfertility patients had had intrauterine operation history or not, their rates of giving live birth increased after the hysteroscopic metroplasty. In conclusion, hysteroscopic metroplasty is an effective intervention for T-shaped uterus patients with fertility intention.
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Affiliation(s)
- Yuxin Zhang
- Department of Reproductive Surgery, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, China
| | - Yiping Zhu
- Department of Reproductive Surgery, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, China
| | - Beilei Ge
- Department of Reproductive Surgery, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, China
| | - Mengsong Sui
- Department of Reproductive Surgery, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, China
| | - Zhenzhen Zheng
- Department of Reproductive Surgery, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, China
| | - Jing Sun
- Department of Reproductive Surgery, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
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Levaillant JM, Rabourdin A, Pinto M, Hurteloup E, Vernet T, Pasquier M, Moquet PY, Massin N. HyFoSy for Fallopian tube test, the how: Sonographic signs and standardization with a simple classification. J Gynecol Obstet Hum Reprod 2022; 51:102307. [PMID: 34986385 DOI: 10.1016/j.jogoh.2021.102307] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/10/2021] [Revised: 11/26/2021] [Accepted: 12/29/2021] [Indexed: 10/19/2022]
Affiliation(s)
- Jean-Marc Levaillant
- Department of Obstetrics, Gynecology and Reproductive Medecine, Intercommunal Hospital, University Paris Est, Créteil, France; Hôpital Privé Armand Brillard, Groupe Ramsay Générale de Santé, Nogent-sur-Marne, France; Clinique la Sagesse, Rennes, France
| | - Anaïs Rabourdin
- Department of Obstetrics, Gynecology and Reproductive Medecine, Intercommunal Hospital, University Paris Est, Créteil, France
| | - Mélodie Pinto
- Department of Obstetrics, Gynecology and Reproductive Medecine, Intercommunal Hospital, University Paris Est, Créteil, France
| | - Edwige Hurteloup
- Department of Obstetrics, Gynecology and Reproductive Medecine, Intercommunal Hospital, University Paris Est, Créteil, France
| | - Thibaut Vernet
- Department of Obstetrics, Gynecology and Reproductive Medecine, Intercommunal Hospital, University Paris Est, Créteil, France
| | - Maud Pasquier
- Department of Obstetrics, Gynecology and Reproductive Medecine, Intercommunal Hospital, University Paris Est, Créteil, France
| | | | - Nathalie Massin
- Department of Obstetrics, Gynecology and Reproductive Medecine, Intercommunal Hospital, University Paris Est, Créteil, France.
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van Welie N, van Rijswijk J, Dreyer K, van Hooff MHA, de Bruin JP, Verhoeve HR, Mol F, van Baal WM, Traas MAF, van Peperstraten AM, Manger AP, Gianotten J, de Koning CH, Koning AMH, Bayram N, van der Ham DP, Vrouenraets FPJM, Kalafusova M, van de Laar BIG, Kaijser J, Lambeek AF, Meijer WJ, Broekmans FJM, Valkenburg O, van der Voet LF, van Disseldorp J, Lambers MJ, Tros R, Lambalk CB, Stoker J, van Wely M, Bossuyt PMM, Mol BWJ, Mijatovic V. OUP accepted manuscript. Hum Reprod 2022; 37:969-979. [PMID: 35220432 PMCID: PMC9071226 DOI: 10.1093/humrep/deac034] [Citation(s) in RCA: 17] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2021] [Revised: 01/27/2022] [Indexed: 11/30/2022] Open
Abstract
STUDY QUESTION Does hysterosalpingo-foam sonography (HyFoSy) lead to similar pregnancy outcomes, compared with hysterosalpingography (HSG), as first-choice tubal patency test in infertile couples? SUMMARY ANSWER HyFoSy and HSG produce similar findings in a majority of patients and clinical management based on the results of either HyFoSy or HSG, leads to comparable pregnancy outcomes. HyFoSy is experienced as significantly less painful. WHAT IS KNOWN ALREADY Traditionally, tubal patency testing during fertility work-up is performed by HSG. HyFoSy is an alternative imaging technique lacking ionizing radiation and iodinated contrast medium exposure which is less expensive than HSG. Globally, there is a shift towards the use of office-based diagnostic methods, such as HyFoSy. STUDY DESIGN, SIZE, DURATION This multicentre, prospective, comparative study with a randomized design was conducted in 26 hospitals in The Netherlands. Participating women underwent both HyFoSy and HSG in randomized order. In case of discordant results, women were randomly allocated to either a management strategy based on HyFoSy or one based on HSG. PARTICIPANTS/MATERIALS, SETTING, METHODS We included infertile women between 18 and 41 years old who were scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male infertility or a known iodine contrast allergy were excluded. The primary outcome for the comparison of the HyFoSy- and HSG-based strategies was ongoing pregnancy leading to live birth within 12 months after inclusion in an intention-to-treat analysis. MAIN RESULTS AND THE ROLE OF CHANCE Between May 2015 and January 2019, 1026 women underwent HyFoSy and HSG. HyFoSy was inconclusive in 97 of them (9.5%), HSG was inconclusive in 30 (2.9%) and both were inconclusive in 9 (0.9%). In 747 women (73%) conclusive tests results were concordant. Of the 143/1026 (14%) with discordant results, 105 were randomized to clinical management based on the results of either HyFoSy or HSG. In this group, 22 of the 54 women (41%) allocated to management based on HyFoSy and 25 of 51 women (49%) allocated to management based on HSG had an ongoing pregnancy leading to live birth (Difference −8%; 95% CI: −27% to 10%). In total, clinical management based on the results of HyFoSy was estimated to lead to a live birth in 474 of 1026 women (46%) versus 486 of 1026 (47%) for management based on HSG (Difference −1.2%; 95% CI: −3.4% to 1.5%). Given the pre-defined margin of −2%, statistically significant non-inferiority of HyFoSy relative to HSG could not be demonstrated (P = 0.27). The mean pain score for HyFoSy on the 1–10 Visual Analogue Scale (VAS) was 3.1 (SD 2.2) and the mean VAS pain score for HSG was 5.4 (SD 2.5; P for difference < 0.001). LIMITATIONS, REASONS FOR CAUTION Since all women underwent both tubal patency tests, no conclusions on a direct therapeutic effect of tubal flushing could be drawn. WIDER IMPLICATIONS OF THE FINDINGS HyFoSy or HSG produce similar tubal pathology findings in a majority of infertile couples and, where they differ, a difference in findings does not lead to substantial difference in pregnancy outcome, while HyFoSy is associated with significantly less pain. STUDY FUNDING/COMPETING INTEREST(S) The FOAM study was an investigator-initiated study funded by ZonMw, The Netherlands organization for Health Research and Development (project number 837001504). ZonMw funded the whole project. IQ Medical Ventures provided the ExEm-foam® kits free of charge. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports travel and speaker fees from Guerbet. F.J.M.B. reports personal fees as a member of the external advisory board for Merck Serono, The Netherlands, and a research support grant from Merck Serono, outside the submitted work. C.B.L. reports speakers’ fee from Ferring in the past, and his department receives research grants from Ferring, Merck and Guerbet. J.S. reports a research agreement with Takeda on MR of motility outside the submitted work. M.V.W. reports leading The Netherlands Satellite of the Cochrane Gynaecology and Fertility Group. B.W.J.M. is supported by an NHMRC Investigator grant (GNT1176437). B.W.J.M. reports consultancy for Guerbet and research funding from Merck and Guerbet. V.M. reports non-financial support from IQ medicals ventures, during the conduct of the study; grants and personal fees from Guerbet, outside the submitted work. The other authors do not report conflicts of interest. TRIAL REGISTRATION NUMBER NTR4746/NL4587 (https://www.trialregister.nl) TRIAL REGISTRATION DATE 19 August 2014 DATE OF FIRST PATIENT’S ENROLMENT 7 May 2015
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Affiliation(s)
- Nienke van Welie
- Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
- Correspondence address. Department of Reproductive Medicine, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1118, 1081 HV Amsterdam, The Netherlands. E-mail:
| | - Joukje van Rijswijk
- Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Kim Dreyer
- Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Machiel H A van Hooff
- Department of Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, The Netherlands
| | - Jan Peter de Bruin
- Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, Den Bosch, The Netherlands
| | - Harold R Verhoeve
- Department of Obstetrics and Gynaecology, OLVG Oost, Amsterdam, The Netherlands
| | - Femke Mol
- Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | | | - Maaike A F Traas
- Department of Obstetrics and Gynaecology, Gelre Hospitals, Location Apeldoorn, Apeldoorn, The Netherlands
| | - Arno M van Peperstraten
- Department of Obstetrics and Gynaecology, Rivierenland Hospital, Tiel, The Netherlands
- Department of Reproductive Medicine and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Arentje P Manger
- Department of Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, The Netherlands
| | - Judith Gianotten
- Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands
| | - Cornelia H de Koning
- Department of Obstetrics and Gynaecology, Tergooi Hospital, Blaricum, The Netherlands
| | - Aafke M H Koning
- Department of Obstetrics and Gynaecology, Amstelland Hospital, Amstelveen, The Netherlands
| | - Neriman Bayram
- Department of Obstetrics and Gynaecology, Zaans Medical Centre, Zaandam, The Netherlands
| | - David P van der Ham
- Department of Obstetrics and Gynaecology, Martini Hospital Groningen, Groningen, The Netherlands
| | | | - Michaela Kalafusova
- Department of Obstetrics and Gynaecology, Refaja Hospital, Stadskanaal, The Netherlands
| | - Bob I G van de Laar
- Department of Obstetrics and Gynaecology, OLVG West, Amsterdam, The Netherlands
| | - Jeroen Kaijser
- Department of Obstetrics and Gynaecology, Ikazia Medical Center, Rotterdam, The Netherlands
| | - Arjon F Lambeek
- Department of Obstetrics and Gynaecology, IJsselland Hospital, Capelle aan den IJssel, The Netherlands
| | - Wouter J Meijer
- Department of Obstetrics and Gynaecology, Gelre Hospitals, Location Zutphen, Zutphen, The Netherlands
| | - Frank J M Broekmans
- Department of Reproductive Medicine and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Olivier Valkenburg
- Department of Reproductive Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Lucy F van der Voet
- Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, The Netherlands
| | - Jeroen van Disseldorp
- Department of Obstetrics and Gynaecology, Sint Antonius Hospital, Nieuwegein, The Netherlands
| | - Marieke J Lambers
- Department of Obstetrics and Gynaecology, Dijklander Hospital, Hoorn, The Netherlands
| | - Rachel Tros
- Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Cornelis B Lambalk
- Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | - Madelon van Wely
- Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
- Department of Epidemiology & Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | - Patrick M M Bossuyt
- Department of Epidemiology & Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | - Ben Willem J Mol
- Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia
- Aberdeen Centre for Women’s Health Research, King’s College, University of Aberdeen, Aberdeen, UK
| | - Velja Mijatovic
- Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
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10
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Welie NV, Ludwin A, Martins WP, Mijatovic V, Dreyer K. Tubal Flushing Treatment for Unexplained Infertility. Semin Reprod Med 2020; 38:74-86. [PMID: 33339062 DOI: 10.1055/s-0040-1721720] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Abstract
Tubal patency testing was initially introduced as a diagnostic test. However, it has been observed that some tubal patency tests also have a therapeutic effect. This therapeutic effect can be influenced by the contrast medium used during tubal flushing. In this review, we discuss current evidence associated with different methods for tubal flushing and their potential impact on reproductive outcomes in women with unexplained infertility. Furthermore, we discuss their diagnostic accuracy, safety, and cost-effectiveness.
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Affiliation(s)
- Nienke van Welie
- Department of Reproductive Medicine, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Artur Ludwin
- Department of Gynecology and Oncology, Jagiellonian University, Krakow, Poland.,Ludwin and Ludwin Gynecology, Private Medical Center, Krakow, Poland.,Centermed, Private Hospital and Clinic, Krakow, Poland
| | - Wellington P Martins
- Department of Obstetrics and Gynecology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil.,Reproductive Medicine, SEMEAR fertilidade, Ribeirao Preto/SP, Brazil
| | - Velja Mijatovic
- Department of Reproductive Medicine, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Kim Dreyer
- Department of Reproductive Medicine, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
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11
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Engels V, Medina M, Antolín E, Ros C, Amaro A, De-Guirior C, Manzour N, Sotillo L, De la Cuesta R, Rodríguez R, San-Frutos L, Peralta S, Martin-Martínez A, Alcázar JL. Feasibility, tolerability, and safety of hysterosalpingo-foam sonography (hyfosy). multicenter, prospective Spanish study. J Gynecol Obstet Hum Reprod 2020; 50:102004. [PMID: 33242678 DOI: 10.1016/j.jogoh.2020.102004] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/10/2020] [Revised: 11/14/2020] [Accepted: 11/19/2020] [Indexed: 10/22/2022]
Abstract
OBJECTIVE To determine the feasibility,tolerability, and safety of the ultrasound assessment of tubal patency using foam as contrast. METHODS This was a prospective multicenter study of 915 infertile nulliparous women scheduled for sonohysterosalpingography with foam instillation (HYFOSY) for tubal patency testing as a part of the fertility workup. Clinical and sonographic data were recorded into a web-shared database. Tubal patency, cervical catheterization, pain during the procedure and post-procedural complications were collected. Patients reported discomfort or pain experienced during the procedure with a visual analogue scale (VAS) score. RESULTS Nine hundred fifteen women were included in the final analysis. Median age was 34 (range, 21-45) years and median body mass index was 23 (range, 16-41) kg/m2. Of 839 women, only 8(0.95 %) cases were abandoned due to impossibility of introducing the intracervical catheter. Most of the cervical os were easily cannulated with either paediatric nasogastric probes or special catheter for intrauterine insemination / sonohysterosalpingography 688/914(75.3 %). With a median instillation of 4 mL (range 1-16) of foam, both tubes were identified in 649/875 (70.9 %) patients, while unilateral patency was observed in 190/875 (20.8 %). Only 36/875 (3.9 %) of the women had bilateral tubal obstruction. The median VAS score for perception of pain during HyFoSy examination was 2 (range 0-10), and only 17 (1.9 %) of women reported severe pain (VAS ≥ 7). Pain was unrelated to tubal patency or tubal blockage. Unexpectedly, difficult cervical catheterizations that needed tenaculum, were more likely associated with mild pain during procedure [nasogastric probe group 176/289 (70.9 %) vs. insemination catheter group 166/399 (41.6 %) vs. tenaculum group 190/218(87.2 %) p < 0.001]. Finally, among 915 patients, we only noticed 3 (0.32 %) complications of the technique: two vasovagal episodes and a mild urinary infection. CONCLUSION HYFOSY is a feasible, well-tolerated and safe technique for the evaluation of tubal patency in infertile women.
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Affiliation(s)
- V Engels
- Hospital Universitario Puerta de Hierro Majadahonda, Spain.
| | - M Medina
- Hospital Materno Infantil Las Palmas de Gran Canaria, Spain
| | - E Antolín
- Hospital Materno Infantil La Paz, Spain
| | - C Ros
- Hospital Clinic Barcelona, Spain
| | - A Amaro
- Hospital Materno Infantil Las Palmas de Gran Canaria, Spain
| | - C De-Guirior
- Hospital Materno Infantil La Paz, Spain; Hospital Clinic Barcelona, Spain
| | - N Manzour
- Clínica Universitaria De Navarra, Spain
| | - L Sotillo
- Hospital Materno Infantil La Paz, Spain
| | - R De la Cuesta
- Hospital Universitario Puerta de Hierro Majadahonda, Spain
| | | | - L San-Frutos
- Hospital Universitario Puerta de Hierro Majadahonda, Spain
| | - S Peralta
- Hospital Materno Infantil Las Palmas de Gran Canaria, Spain
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12
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Szkodziak P, Woźniak A, Szkodziak F, Buszewicz G, Czuczwar P, Woźniak S. Green urine sign after laparoscopic chromopertubation as an effect of severe contrast intravasation: a report of three cases. J Int Med Res 2020; 48:300060520942083. [PMID: 32865060 PMCID: PMC7469741 DOI: 10.1177/0300060520942083] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2020] [Accepted: 06/23/2020] [Indexed: 11/22/2022] Open
Abstract
Tubal diseases are responsible for 25% to 35% of female infertility. Laparoscopic chromopertubation is the gold standard for assessing tubal patency when female infertility is suspected. Intravasation is a complication of intrauterine procedures involving the passage of fluid filling the uterine cavity into the bloodstream through endometrial vessels (from the myometrial veins to the uterine venous plexuses). This complication has been described during hysterosalpingography and sonohysterosalpingography. We herein present a report of three cases in which severe intravasation occurred during laparoscopic chromopertubation using methylene blue as a contrast agent. The intravasation manifested as green urine (i.e., the "green urine sign"). The presence of methylene blue in the urine and blood was confirmed by laboratory tests. All three patients had risk factors for intravasation as described in the literature (unilateral or bilateral tubal obstruction, endometriosis, and previous intrauterine procedures for Mullerian duct anomalies and Asherman's syndrome). The green urine sign appeared a few hours after laparoscopic chromopertubation and spontaneously resolved after 24 hours. Cystoscopy was performed to rule out bladder injury. All three patients required only clinical observation.
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Affiliation(s)
- Piotr Szkodziak
- Third Chair and Department of Gynecology, Medical University of Lublin, Lublin, Poland
| | - Andrzej Woźniak
- Third Chair and Department of Gynecology, Medical University of Lublin, Lublin, Poland
| | - Filip Szkodziak
- Third Chair and Department of Gynecology, Medical University of Lublin, Lublin, Poland
| | - Grzegorz Buszewicz
- Laboratory of Forensic Toxicology, Chair and Department of Forensic Medicine, Medical University of Lublin, Lublin, Poland
| | - Piotr Czuczwar
- Third Chair and Department of Gynecology, Medical University of Lublin, Lublin, Poland
| | - Sławomir Woźniak
- Third Chair and Department of Gynecology, Medical University of Lublin, Lublin, Poland
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13
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Saline-Air Hysterosalpingo-Contrast Sonography Is Equivalent to the Modified Hysterosalpingogram Following Hysteroscopic Sterilization. Ultrasound Q 2020; 36:138-145. [PMID: 32511207 DOI: 10.1097/ruq.0000000000000488] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
PURPOSE To estimate the diagnostic efficacy of saline-air hysterosalpingo-contrast sonography (SA-HyCoSy) compared with the modified hysterosalpingogram (mHSG) for confirmation of both coil location and tubal occlusion following hysteroscopic sterilization. METHODS This study included 19 women who underwent both SA-HyCoSy and mHSG where 1 test was followed by the other. Sensitivity, specificity, and positive and negative predictive values for tubal occlusion against the mHSG were calculated for each fallopian tube by 2 independent interpreters. Interrater reliability was assessed using Cohen κ statistic. Procedure time and pain level by 11-point numeric rating scale of SA-HyCoSy and mHSG were also compared. RESULTS Thirty-eight fallopian tubes were evaluated. Tubal occlusion was noted in 97.3% of tubes for both interpreters with the mHSG compared with 92.1% and 94.7% with SA-HyCoSy. The positive and negative predictive values for tubal occlusion were 100%/100% and 50%/33%, respectively, with an overall agreement of 97.4% and 95.7%, κ = 0.48, P < 0.01. Saline-air HyCoSy changed interpretation of coil insert location in 50% and 44.7% for each interpreter, being downgraded from optimal to satisfactory in 42.9% (9/21) and 36% (9/25) and upgraded to optimal in 58.8% (10/17) and 61.5% (8/13), respectively. There were no statistically significant differences in procedural time (7.5 vs 9.4 minutes, P > 0.05) or maximum pain scores (2.3 vs 3.1, P > 0.05) for the mHSG compared with SA-HyCoSy. CONCLUSIONS Our findings revealed a high degree of diagnostic accuracy with SA-HyCoSy for tubal occlusion, although coil location changed in nearly half of cases. Avoidance of radiation and patient convenience/compliance with SA-HyCoSy may outweigh the drawbacks.
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