A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist.
Infertility is a common complication of endometriosis; while IVF successfully treats endometriosis-associated infertility, pregnancy rates are diminished compared to other etiologies of infertility. The study's long- term objectives are to better identify and treat endometriosis related infertility. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist. 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. Further, use of this approach is limited by the long treatment time required. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. This agent avoids parenteral administration and the prolonged delay in initiation of action as was seen with GnRH agonists. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility. The investigators propose a clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. Participants will include those who agree to be randomized and those who do not want to be randomized. Those who agree to be randomized will be randomly assigned to either the elagolix group or placebo group. Those who do not want to be randomized can choose either the active treatment elagolix and follow the same procedures as those agreeing to be randomized or continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
103
Elagolix tablet
Sugar pill manufactured to mimic Elagolix 200mg
University of Colorado Department of Obstetrics & Gynecology
Aurora, Colorado, United States
Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
New Haven, Connecticut, United States
Northwestern University Department of Obstetrics and Gynecology
Chicago, Illinois, United States
Johns Hopkins, Division of Reproductive Science and Women's Health Research
Baltimore, Maryland, United States
Live birth rate
Live birth rate per participant is defined as live birth at ≥24 weeks of gestation.
Time frame: Up to 15 months
Fertilization rate
Fertilization rate per participant is defined as the rate of \[two pronuclei (2PN)\]/\[total number of oocytes injected or inseminated\]
Time frame: Up to 9 months
Number of embryos transferred
Number of embryos transferred per participant
Time frame: Up to 9 months
Implantation rate
Implantation rate per participant is defined as the rate of (number of gestation sacs visible by Ultrasound) / (Number of Embryo Transfer),
Time frame: Up to 9 months
Biochemical pregnancy rate
Biochemical pregnancy rate per participant is defined as positive pregnancy test following embryo transfer
Time frame: Up to 9 months
Clinical pregnancy rate
Clinical pregnancy rate per participant is defined as ultrasound evidence of intrauterine gestational sac with fetal cardiac activity
Time frame: Up to 10 months
Miscarriage rate
Miscarriage rate among those who achieved pregnancy. Miscarriage is defined as pregnancy loss prior to viability scan and including those confirmed on ultrasound scan up to ≤23+6 weeks of gestation gestation.
Time frame: Up to 10 months
Overall pregnancy complication rate
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Duke Fertility
Morrisville, North Carolina, United States
Overall pregnancy complication rate among those who achieved pregnancy. Overall pregnancy complication including any of the following: preterm delivery, preeclampsia, incidence of abnormal placentation (placenta previa, accreta, increta, percreta, abruption), bleeding in pregnancy (antepartum or postpartum)
Time frame: Up to 15 months
Gestation age at delivery
Gestation age (weeks) at delivery per infant delivered
Time frame: Up to 15 months
Infant birth weight
Infant birth weight (gram) per infant delivered.
Time frame: Up to 15 months