NCT07134920Completed
Norethindrone Impact on Receptiva Outcomes
BCL6 Positivity and ART Outcomes: Comparing Norethindrone Acetate and Depo Lupron for Endometriosis Suppression Prior to Embryo Transfer
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 99 (actual)
- First submitted
- 14 Aug 2025
- Start date
- 12 Aug 2025
- Primary completion date
- 19 Dec 2025
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Diseases
- Endometriosis
- NCT number
- NCT07134920
What you commit to
- Study type: Observational
- Participants enrolled: 99
- From 12 Aug 2025 to the primary completion date, 19 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No prescribed adjuvant therapy (e.g., Lovenox, Neupogen, IVIG)
Other
- Use of both norethinedrone acetate and Depo Leuprolide Acetate in the same treatment cycle
- Incomplete ART or outcome data
- Gestational carrier or egg donor
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Main Line Fertility Coordinator of this site? Confirm its status | Bryn Mawr | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.