NCT07134920

Norethindrone Impact on Receptiva Outcomes

BCL6 Positivity and ART Outcomes: Comparing Norethindrone Acetate and Depo Lupron for Endometriosis Suppression Prior to Embryo Transfer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Inception Fertility Research Institute, LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-08-12
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2025-08-21
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States