Use of Corifolitropin Alfa in Oocyte Donors

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

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)

Study Overview

• Status: Unknown
• Conditions: Infertility; Female Reproductive Problem
• Intervention / Treatment: Drug: Corifollitropin alfa; Drug: Recombinant FSH; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Antonio Requena, MD, PhD; Phone Number: +34 911802900; Email: Antonio.Requena@ivi.es
• Study Contact Backup: Name: María Cruz, PhD; Phone Number: +34 911802900; Email: Maria.Cruz@ivi.es

Study Locations

• Spain
  • Madrid, Spain, 28023
    • Recruiting
    • IVI Madrid
    • Contact: Antonio Requena, MD, PhD; Phone Number: +34 911802900; Email: Antonio.Requena@ivi.es
    • Contact: María Cruz, PhD; Phone Number: +34 911802900; Email: Maria.Cruz@ivi.es
    • Principal Investigator: Antonio Requena, MD, PhD
    • Sub-Investigator: María Cruz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Corifollitropin alfa; Other Names: Elonva 100 micrograms
Experimental: 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.	Drug: Recombinant FSH; Other Names: Puregon 50 IU
Experimental: 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.	Drug: HP-hMG; Other Names: Menopur 600 IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of oocytes and mature oocytes	3 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: IVI Madrid
• Collaborators: Instituto Valenciano de Infertilidad, IVI VALENCIA; Instituto Valenciano de Infertilidad, IVI Alicante
• Investigators: Principal Investigator: Antonio Requena, Md, PhD, IVI Madrid; Study Chair: Manuel Muñoz, MD, PhD, Instituto Valenciano de Infertilidad, IVI Alicante; Study Chair: Pilar Alamá, MD, PhD, IVI Valencia; Study Chair: María Cruz, PhD, IVI Madrid

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 8, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Menotropins
• Other Study ID Numbers: 1403-MAD-013-AR