Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial
Introduction Infertility is a common complication of endometriosis. While in vitro fertilisation-embryo transfer (IVF) successfully treats endometriosis-associated infertility, there is some evidence that pregnancy rates may be diminished in women seeing fertility treatment for endometriosis-associa...
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2022-06-01
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| author | Hugh Taylor Hao Huang Lubna Pal Heping Zhang Howard J Li Sandra Carson Valerie Flores Jared Robbins Nanette F Santoro James H Segars David Seifer Steven Young |
| author_facet | Hugh Taylor Hao Huang Lubna Pal Heping Zhang Howard J Li Sandra Carson Valerie Flores Jared Robbins Nanette F Santoro James H Segars David Seifer Steven Young |
| author_sort | Hugh Taylor |
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| description | Introduction Infertility is a common complication of endometriosis. While in vitro fertilisation-embryo transfer (IVF) successfully treats endometriosis-associated infertility, there is some evidence that pregnancy rates may be diminished in women seeing fertility treatment for endometriosis-associated infertility compared with other etiologies of infertility. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility.Methods and analysis This study is a multicentre, prospective, randomised, double-blind, placebo-controlled trial to study the efficacy of GnRH antagonist pretreatment for women with endometriosis who are undergoing IVF. A total of 814 patients with endometriosis undergoing fertility treatment will be enrolled and randomised 1:1 into two groups: elagolix 200 mg two times per day or placebo for 8 weeks, prior to undergoing IVF. All participants will then undergo IVF treatment per local protocols. The primary outcome is live birth. Secondary outcomes include oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth).Ethics and dissemination The PREGnant trial was approved by the Institutional Review Board at Johns Hopkins University. Results will be published in a peer-reviewed journal.Trial registration number NCT04173169. |
| format | Article |
| id | doaj-art-44fb6bfcf7104f73a079a47a876c3933 |
| institution | Kabale University |
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| language | English |
| publishDate | 2022-06-01 |
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| series | BMJ Open |
| spelling | doaj-art-44fb6bfcf7104f73a079a47a876c39332025-01-24T07:10:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-052043Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trialHugh Taylor0Hao Huang1Lubna Pal2Heping Zhang3Howard J Li4Sandra Carson5Valerie Flores6Jared Robbins7Nanette F Santoro8James H Segars9David Seifer10Steven Young11Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USADepartment of Biostatistics, Yale University School of Public Health, New Haven, Connecticut, USA8 School of Medicine, Yale University, New Haven, Connecticut, USADepartment of Biostatistics, Yale University School of Public Health, New Haven, Connecticut, USAObstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USAObstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USAObstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USAObstetrics and Gynecology, Northwestern University, Evanston, Chicago, USAObstetrics and Gynecology, University of Colorado, Denver, Colorado, USADepartment of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USAObstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USAObstetrics and Gynecology, The University of North Carolina, Chapel Hill, North Carolina, USAIntroduction Infertility is a common complication of endometriosis. While in vitro fertilisation-embryo transfer (IVF) successfully treats endometriosis-associated infertility, there is some evidence that pregnancy rates may be diminished in women seeing fertility treatment for endometriosis-associated infertility compared with other etiologies of infertility. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility.Methods and analysis This study is a multicentre, prospective, randomised, double-blind, placebo-controlled trial to study the efficacy of GnRH antagonist pretreatment for women with endometriosis who are undergoing IVF. A total of 814 patients with endometriosis undergoing fertility treatment will be enrolled and randomised 1:1 into two groups: elagolix 200 mg two times per day or placebo for 8 weeks, prior to undergoing IVF. All participants will then undergo IVF treatment per local protocols. The primary outcome is live birth. Secondary outcomes include oocyte number, fertilisation rate, embryo morphology and implantation rates, as well as rates of known endometriosis-related obstetrical outcomes (pregnancy-induced hypertension, antepartum haemorrhage, caesarean delivery and preterm birth).Ethics and dissemination The PREGnant trial was approved by the Institutional Review Board at Johns Hopkins University. Results will be published in a peer-reviewed journal.Trial registration number NCT04173169.https://bmjopen.bmj.com/content/12/6/e052043.full |
| spellingShingle | Hugh Taylor Hao Huang Lubna Pal Heping Zhang Howard J Li Sandra Carson Valerie Flores Jared Robbins Nanette F Santoro James H Segars David Seifer Steven Young Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial BMJ Open |
| title | Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial |
| title_full | Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial |
| title_fullStr | Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial |
| title_full_unstemmed | Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial |
| title_short | Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial |
| title_sort | pre ivf treatment with a gnrh antagonist in women with endometriosis pregnant study protocol for a prospective double blind placebo controlled trial |
| url | https://bmjopen.bmj.com/content/12/6/e052043.full |
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