Abstract
Background: Clinical management of endometriomas, prior to starting treatment with assisted reproductive technologies (ART), has since long been a matter of debate. Whereas cystectomy has been advocated in the past, recently more evidence has emerged on the potential negative effect of surgery on ovarian reserve. Parallel to this, prolonged downregulation with GnRH-a (gonadotropin-releasing hormone agonists) has been described to improve ART pregnancy rates in women with endometriosis. However, none of these strategies have been assessed in a large randomized controlled trial. The aim of the EndoART study is to assess whether ovarian surgery or prolonged GnRH-a downregulation result in higher pregnancy rates after ART compared to no intervention in women with endometrioma(s). Methods/design: A parallel randomized multi-center trial has been designed to compare ART pregnancy rates in three different treatment groups: no intervention, ovarian surgery, and prolonged hormonal suppression by GnRH-a prior to ART. The primary outcome measure studied is the clinical pregnancy rate with fetal heart-beat within 6 months after initiation of a fresh ART cycle. Secondary outcome measures studied include live birth rate after one initiated fresh ART cycle, cumulative clinical pregnancy rate with fetal heart-beat and live birth rates (after one fully completed ART cycle: initiated fresh + eventual associated frozen embryo transfer cycles), ART–specific data (e.g. number of oocytes, number of good quality embryos), complications, pelvic pain, and quality of life. Conclusion: This trial may answer the most frequently asked questions by both women with endometriosis and physicians: how do you treat endometrioma in women prior to treatment with ART?
| Original language | English |
|---|---|
| Pages (from-to) | 158-173 |
| Number of pages | 16 |
| Journal | Journal of Endometriosis and Pelvic Pain Disorders |
| Volume | 10 |
| Issue number | 3 |
| Early online date | 5 Aug 2018 |
| DOIs | |
| Publication status | Published - 1 Sept 2018 |
Funding
First (and most important), a lack of funding and financial support, despite efforts made by WERF and the authors of this article to attract industry partners. Second, to reach the sufficient power to answer the study question, there is a need for a large international consortium with extensive logistic support to organize this trial, at present not possible with funding by academic resources only. The publication of this protocol is important for future investigators and sponsors, as it has been thoroughly developed according to the state of the art in trial design by a large group of international experts. The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr D’Hooghe reports grants from Merck Serono and Ferring; personal consultancy fees paid to him via Leuven Research and Development for consultancy work for WHO, Actavis, Astellas, Cartagenia, Bayer, Roche, and Proteomika; and clinical trial financial support from Actavis, Roche, and Proteomika, In October 2015, Dr D’Hooghe became Vice-President and Head of Global Medical Affairs Infertility for Merck Serono. He continues on a part-time basis his academic appointment as Professor of Reproductive Medicine at the University of Leuven (KU Leuven) in Belgium and as Adjunct Professor at the Department of Obstetrics and Gynecology at Yale University, New Haven, CT, USA. The work described in this paper was carried out before Dr D’Hooghe joined Merck Serono in October 2015.
Keywords
- ART
- Endometriosis
- gonadotropin-releasing hormone agonist
- operative surgical procedures
- ovarian cyst
- randomized controlled trial