BCL6 Positivity and ART Outcomes: Comparing Norethindrone Acetate and Depo Lupron for Endometriosis Suppression Prior to Embryo Transfer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 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
次要结局
- Miscarriage Rate(From start of treatment to 20 weeks post embryo transfer)
- Live birth rate(From start of treatment to 10 months 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)