Clinical trial NCT02213627: Use of Corifolitropin Alfa in Oocyte Donors
Official title: Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Female Reproductive Problem
Infertility
Keywords: Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation
Lead sponsor: IVI Madrid
Sponsor class: OTHER
Collaborators: name: Instituto Valenciano de Infertilidad, IVI VALENCIA
name: Instituto Valenciano de Infertilidad, IVI Alicante
First posted: 2014-08-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of oocytes and mature oocytes
timeFrame: 3 months
Secondary outcomes:
measure: Fertilization and implantation rates
timeFrame: 3 months
measure: Drop-out rate and cancellation rate
timeFrame: 3 months
measure: Cost-effectiveness analysis
timeFrame: 6 months
measure: Endocrine profile in serum and follicular fluid
timeFrame: 3 months
measure: Apoptosis rate in cumulus cells
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI Madrid
Study officials:
affiliation: IVI Madrid
name: Antonio Requena, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Valenciano de Infertilidad, IVI Alicante
name: Manuel Muñoz, MD, PhD
role: STUDY_CHAIR
affiliation: IVI Valencia
name: Pilar Alamá, MD, PhD
role: STUDY_CHAIR
affiliation: IVI Madrid
name: María Cruz, PhD
role: STUDY_CHAIR
References: