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The goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it aims to answer is whether the generic cetrorelix acetate is non-inferior to the reference product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with luteinizing hormone activity. Daily dose of generic cetrorelix acetate (0.25 mg SC) or original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14 mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg of recombinant human chorionic gonadotropin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic cetrorelix acetate | Experimental |
| |
| Reference cetrorelix acetate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic cetrorelix acetate | Drug | Generic cetrorelix acetate (0.25 mg SC) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative live birth rate | For the first live birth (gestation≥ 24 weeks) in one in vitro fertilization/intracytoplasmic sperm injection egg retrieval cycle (fresh and frozen-thawed embryo transfer cycle) | Through study completion, an average of 18 months |
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Inclusion Criteria:
Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study
Exclusion Criteria:
Subjects could not enter the study if they meet any one of the following criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HE CAI, Doctor | Contact | +8613581613908 | caihe@bjmu.edu.cn | |
| Juanzi Shi, Doctor | Contact | +18602991568 | shijuanziart@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| He Cai | Recruiting | Xi'an | None Selected | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21774931 | Result | Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is a premature rise in luteinizing hormone in the absence of increased progesterone levels detrimental to pregnancy outcome in GnRH antagonist in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):585-9. doi: 10.1016/j.fertnstert.2011.06.042. Epub 2011 Jul 20. | |
| 35595197 | Result |
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| Reference cetrorelix acetate |
| Drug |
reference cetrorelix acetate (0.25 mg SC) |
|
| Liu X, Wen W, Wang T, Tian L, Li N, Sun T, Wang T, Zhou H, Zhang N, Qu P, Mol BW, Li W, Shi J. Increased versus standard gonadotrophin dosing in predicted poor responders of IVF: an open-label randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1806-1815. doi: 10.1093/humrep/deac113. |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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