Norethindrone Impact on Receptiva Outcomes

Completed

Conditions studied: Infertility (IVF Patients), Infertility Female

In brief

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.

Key facts

Study ID: NCT07134920
Run by: Inception Fertility Research Institute, LLC
People needed: 99
Starts: 2025-08-12
Expected to finish: 2025-12-19
Last updated by the study team: 2026-04-15

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Main Line Fertility — Bryn Mawr, Pennsylvania, United States

Full record on ClinicalTrials.gov

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