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Hysteroscopic proximal tubal occlusion versus laparoscopic salpingectomy as a treatment for hydrosalpinges prior to IVF or ICSI: an RCT.
Hum Reprod. 2016 09; 31(9):2005-16.HR

Abstract

STUDY QUESTION

Does hysteroscopic proximal tubal occlusion by intratubal devices as a treatment for hydrosalpinges result in comparable ongoing pregnancy rates following IVF/ICSI when compared with laparoscopic salpingectomy?

SUMMARY ANSWER

Hysteroscopic proximal tubal occlusion by intratubal devices is inferior to laparoscopic salpingectomy in the treatment of hydrosalpinges in women undergoing IVF/ICSI with respect to ongoing pregnancy rates.

WHAT IS KNOWN ALREADY

It is known that women with hydrosalpinges undergoing IVF have poorer pregnancy outcomes compared with women with other forms of tubal infertility. In these women, both laparoscopic salpingectomy and laparoscopic proximal tubal ligation are known to improve IVF outcomes. At present, it is unclear whether a less-invasive hysteroscopic treatment with intratubal devices leads to similar ongoing pregnancy rates following IVF when compared with laparoscopic salpingectomy.

STUDY DESIGN, SIZE, DURATION

A two-centre, randomized, controlled, non-inferiority trial. Between October 2009 and December 2014 a total of 85 women were included in this study; of whom, 42 were randomized to hysteroscopic proximal occlusion by intratubal device placement and 43 were randomized to laparoscopic salpingectomy. Randomization was based on a computer-generated randomization list. The study was unblinded. The primary outcome was ongoing pregnancy rate, defined as a fetal heartbeat on ultrasound beyond 10-week gestation following one IVF/ICSI treatment (fresh and frozen-thawed embryo transfers).

PARTICIPANTS/MATERIALS, SETTING, METHODS

We studied women aged 18-41 years, with uni- or bilateral ultrasound visible hydrosalpinges who were scheduled for an IVF/ICSI treatment.

MAIN RESULTS AND THE ROLE OF CHANCE

The ongoing pregnancy rates per patient according to the intention-to-treat principle were 11/42 (26.2%) after hysteroscopic proximal occlusion by intratubal devices (intervention group) versus 24/43 (55.8%) after laparoscopic salpingectomy (control group) (P = 0.008) [absolute difference: 26.1%; 95% confidence interval (CI): 0.5-51.7, relative risk (RR): 0.56; 95% CI: 0.31-1.03, P = 0.01]. In the per protocol analysis, the ongoing pregnancy rate per patient following hysteroscopic proximal occlusion by intratubal devices was 9/27 (33.3%) compared with 19/32 (59.4%) following laparoscopic salpingectomy (P = 0.067) (absolute difference: 29.6%; 95% CI: 7.1 to 49.1, RR: 0.47; 95% CI: 0.27-0.83, P = 0.062).

LIMITATIONS, REASONS FOR CAUTION

Masking participants and investigators would be difficult due to the nature of both interventions. Since we had objective outcome measurements, we withheld sham procedures, leaving the study unblinded. Furthermore, our low sample size resulted in wide CIs. A larger sample size would result in a more accurate treatment effect; however, this was non-feasible for recruitment and inclusion.

WIDER IMPLICATIONS OF THE FINDINGS

In the treatment of hydrosalpinges prior to IVF/ICSI, hysteroscopic proximal occlusion by intratubal devices is inferior to laparoscopic salpingectomy.

STUDY FUNDING/COMPETING INTERESTS

The intratubal devices were received from Conceptus, Inc., San Carlos, CA, USA, which was acquired by Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA in 2013. Conceptus, Inc./Bayer HealthCare Pharmaceuticals, Inc. had no role in the study design, data collection and analyses, decision to publish or preparation of the manuscript. The study as a whole was funded by the SWOG (foundation for scientific investigation in obstetrics and gynaecology of the VU University Medical Centre, Amsterdam, the Netherlands). P.G.A.H. has received non-financial support from Conceptus, Inc. during the conduct of this study. He has received grants from Ferring B.V., Merck Serono and Abbott outside the submitted work. M.H.E. has received personal fees from Smith and Nephew and IQ Medical Ventures outside the submitted work.

TRIAL REGISTRATION NUMBER

The Dutch Trial Register: NTR 2073.

TRIAL REGISTRATION DATE

October 21, 2009.

DATE OF FIRST PATIENT'S ENROLMENT

October 26, 2009.

Authors+Show Affiliations

Department of Reproductive Medicine, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands k.dreyer@vumc.nl.Department of Reproductive Medicine, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands.Department of Obstetrics and Gynaecology, Spaarne Gasthuis, 2134 Hoofddorp, The Netherlands.Department of Epidemiology and Biostatistics, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands.School of Paediatrics and Reproductive Health, The Robinson Research Institute, Adelaide, Australia.Department of Reproductive Medicine, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands.Department of Reproductive Medicine, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands.Department of Reproductive Medicine, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands.

Pub Type(s)

Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27209341

Citation

Dreyer, K, et al. "Hysteroscopic Proximal Tubal Occlusion Versus Laparoscopic Salpingectomy as a Treatment for Hydrosalpinges Prior to IVF or ICSI: an RCT." Human Reproduction (Oxford, England), vol. 31, no. 9, 2016, pp. 2005-16.
Dreyer K, Lier MC, Emanuel MH, et al. Hysteroscopic proximal tubal occlusion versus laparoscopic salpingectomy as a treatment for hydrosalpinges prior to IVF or ICSI: an RCT. Hum Reprod. 2016;31(9):2005-16.
Dreyer, K., Lier, M. C., Emanuel, M. H., Twisk, J. W., Mol, B. W., Schats, R., Hompes, P. G., & Mijatovic, V. (2016). Hysteroscopic proximal tubal occlusion versus laparoscopic salpingectomy as a treatment for hydrosalpinges prior to IVF or ICSI: an RCT. Human Reproduction (Oxford, England), 31(9), 2005-16. https://doi.org/10.1093/humrep/dew050
Dreyer K, et al. Hysteroscopic Proximal Tubal Occlusion Versus Laparoscopic Salpingectomy as a Treatment for Hydrosalpinges Prior to IVF or ICSI: an RCT. Hum Reprod. 2016;31(9):2005-16. PubMed PMID: 27209341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Hysteroscopic proximal tubal occlusion versus laparoscopic salpingectomy as a treatment for hydrosalpinges prior to IVF or ICSI: an RCT. AU - Dreyer,K, AU - Lier,M C I, AU - Emanuel,M H, AU - Twisk,J W R, AU - Mol,B W J, AU - Schats,R, AU - Hompes,P G A, AU - Mijatovic,V, Y1 - 2016/05/21/ PY - 2015/08/31/received PY - 2016/02/19/accepted PY - 2016/5/23/entrez PY - 2016/5/23/pubmed PY - 2018/2/1/medline KW - Essure® device KW - IVF KW - hydrosalpinges KW - pregnancy outcome KW - salpingectomy KW - tubal infertility SP - 2005 EP - 16 JF - Human reproduction (Oxford, England) JO - Hum Reprod VL - 31 IS - 9 N2 - STUDY QUESTION: Does hysteroscopic proximal tubal occlusion by intratubal devices as a treatment for hydrosalpinges result in comparable ongoing pregnancy rates following IVF/ICSI when compared with laparoscopic salpingectomy? SUMMARY ANSWER: Hysteroscopic proximal tubal occlusion by intratubal devices is inferior to laparoscopic salpingectomy in the treatment of hydrosalpinges in women undergoing IVF/ICSI with respect to ongoing pregnancy rates. WHAT IS KNOWN ALREADY: It is known that women with hydrosalpinges undergoing IVF have poorer pregnancy outcomes compared with women with other forms of tubal infertility. In these women, both laparoscopic salpingectomy and laparoscopic proximal tubal ligation are known to improve IVF outcomes. At present, it is unclear whether a less-invasive hysteroscopic treatment with intratubal devices leads to similar ongoing pregnancy rates following IVF when compared with laparoscopic salpingectomy. STUDY DESIGN, SIZE, DURATION: A two-centre, randomized, controlled, non-inferiority trial. Between October 2009 and December 2014 a total of 85 women were included in this study; of whom, 42 were randomized to hysteroscopic proximal occlusion by intratubal device placement and 43 were randomized to laparoscopic salpingectomy. Randomization was based on a computer-generated randomization list. The study was unblinded. The primary outcome was ongoing pregnancy rate, defined as a fetal heartbeat on ultrasound beyond 10-week gestation following one IVF/ICSI treatment (fresh and frozen-thawed embryo transfers). PARTICIPANTS/MATERIALS, SETTING, METHODS: We studied women aged 18-41 years, with uni- or bilateral ultrasound visible hydrosalpinges who were scheduled for an IVF/ICSI treatment. MAIN RESULTS AND THE ROLE OF CHANCE: The ongoing pregnancy rates per patient according to the intention-to-treat principle were 11/42 (26.2%) after hysteroscopic proximal occlusion by intratubal devices (intervention group) versus 24/43 (55.8%) after laparoscopic salpingectomy (control group) (P = 0.008) [absolute difference: 26.1%; 95% confidence interval (CI): 0.5-51.7, relative risk (RR): 0.56; 95% CI: 0.31-1.03, P = 0.01]. In the per protocol analysis, the ongoing pregnancy rate per patient following hysteroscopic proximal occlusion by intratubal devices was 9/27 (33.3%) compared with 19/32 (59.4%) following laparoscopic salpingectomy (P = 0.067) (absolute difference: 29.6%; 95% CI: 7.1 to 49.1, RR: 0.47; 95% CI: 0.27-0.83, P = 0.062). LIMITATIONS, REASONS FOR CAUTION: Masking participants and investigators would be difficult due to the nature of both interventions. Since we had objective outcome measurements, we withheld sham procedures, leaving the study unblinded. Furthermore, our low sample size resulted in wide CIs. A larger sample size would result in a more accurate treatment effect; however, this was non-feasible for recruitment and inclusion. WIDER IMPLICATIONS OF THE FINDINGS: In the treatment of hydrosalpinges prior to IVF/ICSI, hysteroscopic proximal occlusion by intratubal devices is inferior to laparoscopic salpingectomy. STUDY FUNDING/COMPETING INTERESTS: The intratubal devices were received from Conceptus, Inc., San Carlos, CA, USA, which was acquired by Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA in 2013. Conceptus, Inc./Bayer HealthCare Pharmaceuticals, Inc. had no role in the study design, data collection and analyses, decision to publish or preparation of the manuscript. The study as a whole was funded by the SWOG (foundation for scientific investigation in obstetrics and gynaecology of the VU University Medical Centre, Amsterdam, the Netherlands). P.G.A.H. has received non-financial support from Conceptus, Inc. during the conduct of this study. He has received grants from Ferring B.V., Merck Serono and Abbott outside the submitted work. M.H.E. has received personal fees from Smith and Nephew and IQ Medical Ventures outside the submitted work. TRIAL REGISTRATION NUMBER: The Dutch Trial Register: NTR 2073. TRIAL REGISTRATION DATE: October 21, 2009. DATE OF FIRST PATIENT'S ENROLMENT: October 26, 2009. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/27209341/Hysteroscopic_proximal_tubal_occlusion_versus_laparoscopic_salpingectomy_as_a_treatment_for_hydrosalpinges_prior_to_IVF_or_ICSI:_an_RCT_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dew050 DB - PRIME DP - Unbound Medicine ER -