Norethindrone Impact on Receptiva Outcomes

NCT ID: NCT07134920

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2026-07-31

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 transfer. The current standard of care involves treatment with Depo Lupron, a GnRH agonist associated with significant hypoestrogenic side effects that mimic menopausal symptoms. Additionally, Depo Lupron is costly, with a retail price exceeding $2,000 per dose. In contrast, norethindrone acetate is a well-tolerated oral progestin, available at a fraction of the cost (under $100 for a one-month course). While prior studies have demonstrated comparable efficacy between Depo Lupron and norethindrone for managing endometriosis-associated pain, their relative effectiveness in improving reproductive outcomes-particularly in BCL6-positive patients undergoing embryo transfer-remains underexplored. This study seeks to address that gap by comparing ongoing pregnancy, live birth, and miscarriage rates between the two treatment groups.

Hypothesis: IVF Patients testing positive for BCL6 and treated with norethindrone will not do worse than the current recommended treatment of 60 days Depo leuprolide as defined by two endpoint metrics, pregnancy rate and live birth rate.

Conditions

Infertility (IVF Patients); Infertility Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Norethindrone acetate Group

Patients who received 6 and 8 weeks of suppression with norethindrone acetate prior to embryo transfer cycle

No interventions assigned to this group

Depo Leuprolide Group

Patients who received two monthly injections of Depo Leuprolide Acetate prior to embryo transfer cycle

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cicero Diagnostic

UNKNOWN

Sponsor Role: collaborator

Inception Fertility Research Institute, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Main Line Fertility

Bryn Mawr, Pennsylvania, United States

Countries

United States

Other Identifiers

IRI-MLF-2025-002

Identifier Type: -

Identifier Source: org_study_id