Norethindrone Impact on Receptiva Outcomes

NCT07134920 | Completed

• 1 other identifier: IRI-MLF-2025-002
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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

Keywords

Receptiva; Depo Lupron Acetate; Norethindrone Acetate

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  To compare ongoing pregnancy rates in BCL6-positive patients treated with norethindrone acetate versus Depo Lupron acetate

  From beginning of treatment to 12 weeks post embryo transfer

Secondary Outcomes (4)

• Live birth rate

  From start of treatment to 10 months post embryo transfer

• Miscarriage Rate

  From start of treatment to 20 weeks post embryo transfer

• Biochemical pregnancy rate

  From start of treatment to 4 weeks post embryo transfer

• Ectopic pregnancy rate

  From start of treatment to 8 weeks post embryo transfer

Study Arms (2)

Norethindrone acetate Group

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

Depo Leuprolide Group

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with a ReceptivaDx BCL6-positive test who completed hormonal suppression therapy prior to embryo transfer cycle

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)

Sponsors & Collaborators

• Inception Fertility Research Institute, LLC: lead
• Cicero Diagnostic: collaborator

Study Sites (1)

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010, United States

Location

MeSH Terms

Conditions

Infertility; Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: August 12, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)