Status:
COMPLETED
Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis
Lead Sponsor:
Colorado Center for Reproductive Medicine
Collaborating Sponsors:
AbbVie
Conditions:
Infertility
Endometriosis
Eligibility:
FEMALE
21-42 years
Phase:
EARLY_PHASE1
Brief Summary
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 tes...
Detailed Description
1. Baseline visit prior to initiation of IVF cycle: Review nature of study, confirm surgical diagnosis of endometriosis, obtain informed consent, confirm absence of exclusion criteria 2. Standard ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Age \<21 or \> 42 years at time of initiation of IVF cycle
- 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
- Planned use of donor oocytes or embryos
- Planned use of gestational carrier
- 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
- Unwilling to abide by study parameters or sign informed consent
- No documentation of surgical diagnosis of endometriosis with study timeline (10 years of study entry)
- Absence of embryos predicted to be euploid available for transfer (embryos with no results may not be included in transfer)
- Prior adverse reaction to any GnRH agonist or antagonist
- Uncorrected or uncorrectable clinically relevant uterine cavity abnormalities or hydrosalpinx
- Acute or chronic renal, pulmonary, hepatic, or cardiac disease
- Prior diagnosis of pituitary adenoma or any other intracranial lesion
- Menstrual cycles outside the range of inclusion criteria
- Diagnosis of polycystic ovary syndrome (PCOS)
- Pregnancy prior to study initiation or initiation of endometrial preparation for embryo transfer.
- Undiagnosed vaginal bleeding
- Clinically relevant adenomyosis as diagnosed by baseline 3D ultrasound exam (and/or MRI if felt to be appropriate)
- Bipolar disorder, history of suicidal ideation, any other psychiatric disorder requiring lithium or anti-psychotic medications
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04445025
Start Date
September 1 2020
End Date
December 30 2024
Last Update
February 20 2025
Active Locations (1)
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1
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, United States, 80124