Use of Corifolitropin Alfa in Oocyte Donors

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02213627
• Other study ID #: 1403-MAD-013-AR
• Status: Unknown status
• Phase: Phase 4
• First received: August 8, 2014
• Last updated: July 16, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: IVI Madrid
• Contact: Antonio Requena, MD, PhD
• Phone: +34 911802900
• Email: Antonio.Requena[@]ivi.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Reproductive Problem
• Infertility

Intervention

Drug:
• Corifollitropin alfa

• Recombinant FSH

• HP-hMG

Locations

Country	Name	City	State
Spain	IVI Madrid	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
IVI Madrid	Instituto Valenciano de Infertilidad, IVI Alicante, Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes and mature oocytes		3 months
Secondary	Fertilization and implantation rates		3 months
Secondary	Drop-out rate and cancellation rate		3 months
Secondary	Cost-effectiveness analysis		6 months
Secondary	Endocrine profile in serum and follicular fluid		3 months
Secondary	Apoptosis rate in cumulus cells		6 months