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Use of Corifolitropin Alfa in Oocyte Donors

Sponsor
IVI Madrid (Other)
Overall Status
Unknown status
CT.gov ID
NCT02213627
Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA (Other), Instituto Valenciano de Infertilidad, IVI Alicante (Other)
300
Enrollment
1
Location
3
Arms
14
Duration (Months)
21.4
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Corifollitropin alfa
  • Drug: Recombinant FSH
  • Drug: HP-hMG
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of oocytes and mature oocytes [3 months]

    Secondary Outcome Measures

    1. Fertilization and implantation rates [3 months]

    2. Drop-out rate and cancellation rate [3 months]

    3. Cost-effectiveness analysis [6 months]

    4. Endocrine profile in serum and follicular fluid [3 months]

    5. Apoptosis rate in cumulus cells [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVI Madrid Madrid Spain 28023

    Sponsors and Collaborators

    • IVI Madrid
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonio Requena, MD, PhD, IVI Madrid
    ClinicalTrials.gov Identifier:
    NCT02213627
    Other Study ID Numbers:
    • 1403-MAD-013-AR
    First Posted:
    Aug 11, 2014
    Last Update Posted:
    Jul 17, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by Antonio Requena, MD, PhD, IVI Madrid
    Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation
    Additional relevant MeSH terms:
    Infertility
    Menotropins

    Study Results

    No Results Posted as of Jul 17, 2015