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Completed

NCT Number: NCT07134920

Norethindrone Impact on Receptiva Outcomes

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.

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Key information

Conditions

Infertility (IVF Patients) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility Female Infertility, Female Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Main Line Fertility

Bryn Mawr, Pennsylvania, 19010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: From beginning of treatment to 12 weeks post embryo transfer

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

Secondary outcomes

  1. Live birth rate

    Time frame: From start of treatment to 10 months post embryo transfer

    To compare live birth rates in BCL6-positive patients treated with norethindrone acetate versus Depo Lupron acetate

  2. Miscarriage Rate

    Time frame: From start of treatment to 20 weeks post embryo transfer

    Defined as the loss of a clinically confirmed pregnancy before 20 weeks of gestation

  3. Biochemical pregnancy rate

    Time frame: From start of treatment to 4 weeks post embryo transfer

    Defined as a low positive serum HCG with an inappropriate rise, spontaneous resolution

  4. Ectopic pregnancy rate

    Time frame: From start of treatment to 8 weeks post embryo transfer

Sponsors and collaborators

Lead sponsor

Inception Fertility Research Institute, LLC

Industry

Collaborators

  • Cicero Diagnostic

Registry information

Official study title

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

Acronym: NIRO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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