Status:
COMPLETED
Elagolix for Fertility Enhancement Clinical Trial
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Stanford University
Conditions:
Endometriosis
Unexplained Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE2
Brief Summary
Studies suggest that undiagnosed endometriosis results in poor reproductive outcomes in the setting of In Vitro Fertilization and Embryo Transfer (IVF-ET). Biomarkers that predict endometriosis includ...
Detailed Description
Although meta-analyses have not demonstrated an effect of endometriosis on IVF outcomes, most women with endometriosis undergoing IVF have not been diagnosed or treated for their disease. Recent evide...
Eligibility Criteria
Inclusion
- Anti-Mullerian Hormone (AMH) \> 0.5 and \< 10
- At least 1 euploid embryo for transfer
- Prior endometrial biopsy showing elevated BCL6 and SIRT1 expression
- Endometrial thickness \> 5.9 and \< 14 mm
Exclusion
- Uterine fibroids \> 4 cm (intramural)
- Polycystic ovary syndrome (Rotterdam criteria)
- Ovarian failure and donor eggs or oocytes
- Positive lupus anticoagulant or positive anti-cardiolipin antibody testing
- Diabetes mellitus (Type I or II)
- Untreated hypothyroidism
- Untreated hyperprolactinemia
- BMI \<17 or \> 35
- Uncorrected uterine anomaly
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04039204
Start Date
January 15 2022
End Date
August 9 2023
Last Update
July 26 2024
Active Locations (1)
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1
Wake Forest Univesity Health Sciences
Winston-Salem, North Carolina, United States, 27157