Corifollitropin Alfa Versus Follitropin Beta in High Responders

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial (RCT) is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for in vitro fertilization treatment using a gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger and cryopreservation of all embryos.

Detailed Description
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Corifollitropin alfa, a novel fusion protein lacking luteinizing hormone (LH) activity, has a longer elimination half-life and extended time to peak levels than recombinant follicle stimulating hormone (rFSH). A single injection of corifollitropin alfa may replace seven daily injections follitropin beta during the first week of ovarian stimulation, reducing patient discomfort. The purpose of this RCT is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, as well as hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for IVF using a GnRH antagonist protocol. In addition, incidence of unexpected ovarian hyperstimulation syndrome (OHSS) will be evaluated, although it is anticipated that GnRH agonist triggering will eliminate occurrence of the syndrome.

Official Title
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Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial

Conditions
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Infertility

Intervention / Treatment
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* Drug: Elonva
* Drug: Puregon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-40 years Polycystic ovaries (PCO) or polycystic ovary syndrome (PCOS) no endometriotic cyst Exclusion Criteria: Patients with poor response Patients using human chorionic gonadotropin (hCG) for triggering final oocyte maturation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Puregon<br>Patients will undergo ovarian stimulation using daily injections of recombinant FSH (Puregon), as performed traditionally in IVF cycles | Drug: Puregon<br>* follitropin beta (Puregon): daily injections 150 IU from Day 2/3 of menstrual cycle until adequate follicle development is achieved<br>* Other names: follitropin beta;|
| Experimental: Elonva<br>Patients will undergo ovarian stimulation using a single injection of corifollitropin alfa (Elonva) | Drug: Elonva<br>* corifollitropin alfa (Elonva): a single injection 100 or 150 ug (depending on patient body weight) on Day 2/3 of menstrual cycle<br>* Other names: corifollitropin alfa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | Day of oocyte retrieval (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe OHSS |  | up to 5 days post oocyte retrieval | 
| Follicle development |  | Day of triggering final oocyte maturation = last day of ovarian stimulation (Day -2 prior to oocyte retrieval) | 
| Fertilization rate |  | Day 1 after oocyte retrieval | 
| Blastocyst formation rates |  | Day 5/6 after oocyte retrieval | 
| Number of blastocysts cryopreserved |  | Day 5/6 after oocyte retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high responders, follitropin beta, Ovarian stimulation, corifollitropin alfa, GnRH antagonist protocol