Use of Corifolitropin Alfa in Oocyte Donors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant FSH or HP-hMG)

Detailed Description
-----------------
In recent years, increasingly advances have been developed in terms of controlled ovarian stimulation protocols. These improvements have also moved into the way of administration of the different treatments, and at present, with subcutaneous devices, it is possible to offer advantages such as the ability to ensure administration of the correct dose or modify the dose before charging. Simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate. The need for daily injection does not worsen the degree of compliance, but it generates some anxiety related to the administration of the right dose and / or the possibility of making a unconsciously mistake . Innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor. Given these considerations, the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established. Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect of stimulation; a single subcutaneous injection of this drug is able to replace the first seven injections of any daily FSH preparation, so finally, the result would be an overall decrease in the number of injections needed for the whole cycle. Pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor, including fewer clinic visits.

Official Title
-----------------
Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG

Conditions
-----------------
Female Reproductive Problem, Infertility

Intervention / Treatment
-----------------
* Drug: Corifollitropin alfa
* Drug: Recombinant FSH
* Drug: HP-hMG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-35 years who meet the entry criteria for the IVI Donor Program: Weight < 60 Kg Women with at least 6 antral follicles per ovary Women who will fit the protocoo during the period of the study Women who give written consent to participate in the test Exclusion Criteria: Women with basal antral follicle count above 20 or below 6. Women with comorbidities, in the judgement of the investigator, that may interfere with the trearment of ovarian stimulation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corifollitropin alfa<br>From day 2-3 of mense, a single 100 microgram dose of corifollitropin alfa is administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. | Drug: Corifollitropin alfa<br> <br> * Other names: Elonva 100 micrograms;|
| Experimental: Recombinant FSH<br>From day 2-3 of mense, daily injections of 150 IU of recombinant FSH will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. | Drug: Recombinant FSH<br> <br> * Other names: Puregon 50 IU;|
| Experimental: HP-hMG<br>From day 2-3 of mense, daily doses of 225 IU of HP-hMG will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation. | Drug: HP-hMG<br> <br> * Other names: Menopur 600 IU;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes and mature oocytes |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization and implantation rates |  | 3 months | 
| Drop-out rate and cancellation rate |  | 3 months | 
| Cost-effectiveness analysis |  | 6 months | 
| Endocrine profile in serum and follicular fluid |  | 3 months | 
| Apoptosis rate in cumulus cells |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation