Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

Prior treatment

• 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
• No documentation of surgical diagnosis of endometriosis with study timeline (10 years of study entry)
• Prior adverse reaction to any GnRH agonist or antagonist
• Prior diagnosis of pituitary adenoma or any other intracranial lesion
• Pregnancy prior to study initiation or initiation of endometrial preparation for embryo transfer.

Other illness

• Acute or chronic renal, pulmonary, hepatic, or cardiac disease
• Diagnosis of polycystic ovary syndrome (PCOS)
• Undiagnosed vaginal bleeding
• Bipolar disorder, history of suicidal ideation, any other psychiatric disorder requiring lithium or anti-psychotic medications

Lab values

• 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

Age

• Age \<21 or \> 42 years at time of initiation of IVF cycle

Other

• Planned use of donor oocytes or embryos
• Planned use of gestational carrier
• Unwilling to abide by study parameters or sign informed consent
• Absence of embryos predicted to be euploid available for transfer (embryos with no results may not be included in transfer)
• Uncorrected or uncorrectable clinically relevant uterine cavity abnormalities or hydrosalpinx
• Menstrual cycles outside the range of inclusion criteria
• Clinically relevant adenomyosis as diagnosed by baseline 3D ultrasound exam (and/or MRI if felt to be appropriate)

• Diagnosis of infertility who are candidate for IVF
• Surgical diagnosis of endometriosis within 10 years of study entry
• Willing to sign/give informed consent and adhere to parameters of study
• Normal endometrial cavity as diagnosed by 3D ultrasound and office hysteroscopy examinations at baseline or after correction of underlying clinically relevant cavity abnormalities
• 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
• No contraindication to GnRH agonist or GnRH antagonist use
• No prolonged use of GnRH agonist or antagonist (\> 30 consecutive days) or other treatment for endometriosis within 4 months of study entry
• Have at least one euploid embryo available for transfer
• Agrees to transfer best quality embryo as determined by CCRM physician and embryology team
• Regular menses ranging from 22-36 days
• Agrees to use barrier contraception throughout GnRH agonist or antagonist administration
• No evidence of untreated hydrosalpinx