Status:
ACTIVE_NOT_RECRUITING
Norethindrone Impact on Receptiva Outcomes
Lead Sponsor:
Inception Fertility Research Institute, LLC
Collaborating Sponsors:
Cicero Diagnostic
Conditions:
Infertility (IVF Patients)
Infertility Female
Eligibility:
FEMALE
Brief Summary
This retrospective study aims to evaluate pregnancy outcomes in patients with a positive BCL6 test (ReceptivaDx, who were treated with either norethindrone acetate or Depo Lupron prior to embryo trans...
Eligibility Criteria
Inclusion
- Diagnosis of recurrent pregnancy loss, recurrent implantation failure, unexplained infertility or severe dysmenorrhea and a positive BCL6 test Receptivadx
- Underwent assisted reproductive technology (ART or IVF)
- Treated with norethinedrone acetate 5 mg daily for 6 and 8 weeks or two monthly injections of Depo Leuprolide Acetate 7.5mg rior to embryo transfer cycle
- Euploid embryo transfer cycle was initiated within 1 week of completion of suppression protocol
- Adequate clinical documentation available, including treatment protocol, BCL6 results, and pregnancy outcomes
- If Endometrial Receptivity Analysis (ERA) was performed, result must be "receptive"
- A minimum uterine lining of 7.5mm was documented by ultrasound prior to the initiation of progesterone
Exclusion
- Use of both norethinedrone acetate and Depo Leuprolide Acetate in the same treatment cycle
- Incomplete ART or outcome data
- Gestational carrier or egg donor
- No prescribed adjuvant therapy (e.g., Lovenox, Neupogen, IVIG)
Key Trial Info
Start Date :
August 12 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT07134920
Start Date
August 12 2025
End Date
July 1 2026
Last Update
August 21 2025
Active Locations (1)
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1
Main Line Fertility
Bryn Mawr, Pennsylvania, United States, 19010