D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: corifollitropin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 36 years old on day of randomisation FSH < 12 (in the early follicular phase) Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation. Regular menstrual cycles of 21-35 days, presumed to be ovulatory. BMI ≤ 29 Weight > 60 kg < 3 previous trials ICSI Randomisation at out-patient clinic Exclusion Criteria: ≥ 36 years old on day of randomisation Endometriosis ≥ grade 3 PCOS Poor responders (development of < 4 follicles in a previous IVF/ICSI cycle) Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Day 2 group<br>Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol. | Drug: corifollitropin alfa<br>* long acting FSH<br>|
| Active Comparator: Day 4 group<br>Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa | Drug: corifollitropin alfa<br>* long acting FSH<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | The purpose is to study the pregnancy rate in each treatment group | Up to 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICSI, GnRH antagonist, corifollitropin alfa