Use of Corifolitropin Alfa in Oocyte Donors

NCT ID: NCT02213627

Last Updated: 2015-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Female Reproductive Problem; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corifollitropin alfa

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.

Group Type: EXPERIMENTAL

Corifollitropin alfa

Intervention Type: DRUG

Recombinant FSH

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.

Group Type: EXPERIMENTAL

Recombinant FSH

Intervention Type: DRUG

HP-hMG

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.

Group Type: EXPERIMENTAL

HP-hMG

Intervention Type: DRUG

Interventions

Corifollitropin alfa

Intervention Type: DRUG

Recombinant FSH

Intervention Type: DRUG

HP-hMG

Intervention Type: DRUG

Other Intervention Names

Elonva 100 micrograms; Puregon 50 IU; Menopur 600 IU

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: collaborator

Instituto Valenciano de Infertilidad, IVI Alicante

OTHER

Sponsor Role: collaborator

IVI Madrid

OTHER

Sponsor Role: lead

Responsible Party

Antonio Requena

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Requena, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Manuel Muñoz, MD, PhD

Role: STUDY_CHAIR

Instituto Valenciano de Infertilidad, IVI Alicante

Pilar Alamá, MD, PhD

Role: STUDY_CHAIR

IVI Valencia

María Cruz, PhD

Role: STUDY_CHAIR

IVI Madrid

Locations

IVI Madrid

Madrid, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Antonio Requena, MD, PhD

Role: CONTACT

Antonio.Requena@ivi.es

+34 911802900

María Cruz, PhD

Role: CONTACT

Maria.Cruz@ivi.es

+34 911802900

Facility Contacts

Antonio Requena, MD, PhD

Role: primary

Antonio.Requena@ivi.es

+34 911802900

María Cruz, PhD

Role: backup

Maria.Cruz@ivi.es

+34 911802900

Other Identifiers

1403-MAD-013-AR

Identifier Type: -

Identifier Source: org_study_id