The Effect of Elagolix in Comparison to Leuprolide Acetate on in Vitro Fertilization (IVF) Cycle Outcomes After a Transfer of Euploid Embryos to Patients With Surgically Diagnosed Endometriosis: A Pilot Trial

elagolix

Patients who have been previously surgically diagnosed with endometriosis and have embryos predicted to be euploid after in vitro fertilization will be divided into 2 groups via randomization. The test group will receive Elagolix for 60 days prior to starting frozen embryo transfer preparation. The control group will be given leuprolide acetate every 28 days x 2 prior to starting the frozen embryo transfer preparation. Comparative implantation rates between two groups of patients will be evaluated

2020-09-01

2024-09-30

2024-12-30

Active (not recruiting)

Early phase I

30

Inclusion Criteria: 1. Diagnosis of infertility who are candidate for IVF 2. Surgical diagnosis of endometriosis within 10 years of study entry 3. Willing to sign/give informed consent and adhere to parameters of study 4. Normal endometrial cavity as diagnosed by 3D ultrasound and office hysteroscopy examinations at baseline or after correction of underlying clinically relevant cavity abnormalities 5. Day 2-4 serum FSH level ≤ 12 mIu/mL and/or random serum AMH level ≥ 0.9 ng/mL and/or antral follicular phase follicle count obtained by trans-vaginal ultrasound examination ≥ 5 6. No contraindication to GnRH agonist or GnRH antagonist use 7. No prolonged use of GnRH agonist or antagonist (\> 30 consecutive days) or other treatment for endometriosis within 4 months of study entry 8. Have at least one euploid embryo available for transfer 9. Agrees to transfer best quality embryo as determined by CCRM physician and embryology team 10. Regular menses ranging from 22-36 days 11. Agrees to use barrier contraception throughout GnRH agonist or antagonist administration 12. No evidence of untreated hydrosalpinx Exclusion Criteria: 1. Age \<21 or \> 42 years at time of initiation of IVF cycle 2. Day 2-4 FSH level \>12 mIu/mL or random serum AMH level \<1.0 ng/mL and antral follicle count obtained by trans-vaginal ultrasound examination \< 5 3. Planned use of donor oocytes or embryos 4. Planned use of gestational carrier 5. Use of GnRH agonist, GnRH antagonist or other approved medical therapy for endometriosis (with the exception of combination contraceptives) for \> 30 consecutive days prior to study entry 6. Unwilling to abide by study parameters or sign informed consent 7. No documentation of surgical diagnosis of endometriosis with study timeline (10 years of study entry) 8. Absence of embryos predicted to be euploid available for transfer (embryos with no results may not be included in transfer) 9. Prior adverse reaction to any GnRH agonist or antagonist 10. Uncorrected or uncorrectable clinically relevant uterine cavity abnormalities or hydrosalpinx 11. Acute or chronic renal, pulmonary, hepatic, or cardiac disease 12. Prior diagnosis of pituitary adenoma or any other intracranial lesion 13. Menstrual cycles outside the range of inclusion criteria 14. Diagnosis of polycystic ovary syndrome (PCOS) 15. Pregnancy prior to study initiation or initiation of endometrial preparation for embryo transfer. 16. Undiagnosed vaginal bleeding 17. Clinically relevant adenomyosis as diagnosed by baseline 3D ultrasound exam (and/or MRI if felt to be appropriate) 18. Bipolar disorder, history of suicidal ideation, any other psychiatric disorder requiring lithium or anti-psychotic medications

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Test group will receive Elagolix 60 days prior to initiating frozen embryo transfer preparation.\n\nControl group will receive depot leuprolide twice (once every 28 days) prior to initiation frozen embryo transfer preparation.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-02-29