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| Name | Class |
|---|---|
| Cicero Diagnostic | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | To compare live birth rates in BCL6-positive patients treated with norethindrone acetate versus Depo Lupron acetate | From start of treatment to 10 months post embryo transfer |
| Miscarriage Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Women with a ReceptivaDx BCL6-positive test who completed hormonal suppression therapy prior to embryo transfer cycle
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Fertility | Bryn Mawr | Pennsylvania | 19010 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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Defined as the loss of a clinically confirmed pregnancy before 20 weeks of gestation
| From start of treatment to 20 weeks post embryo transfer |
| Biochemical pregnancy rate | Defined as a low positive serum HCG with an inappropriate rise, spontaneous resolution | From start of treatment to 4 weeks post embryo transfer |
| Ectopic pregnancy rate | From start of treatment to 8 weeks post embryo transfer |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |