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The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.
Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Day 2 group | Placebo Comparator | Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol. |
|
| Day 4 group | Active Comparator | Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corifollitropin alfa | Drug | long acting FSH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of rFSH at the end of the follicular phase | The purpose is to assess the additional need for recFSH in each treatment group | up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | The purpose is to study the pregnancy rate in each treatment group | Up to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24813196 | Derived | Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. doi: 10.1093/humrep/deu105. Epub 2014 May 9. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
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