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Use of Corifolitropin Alfa in Oocyte Donors

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ClinicalTrials.gov Identifier: NCT02213627
Recruitment Status : Unknown
Verified July 2015 by Antonio Requena, IVI Madrid.
Recruitment status was:  Recruiting
First Posted : August 11, 2014
Last Update Posted : July 17, 2015
Sponsor:
Collaborators:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Instituto Valenciano de Infertilidad, IVI Alicante
Information provided by (Responsible Party):
Antonio Requena, IVI Madrid

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
Female Reproductive Problem Infertility 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

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 Name: 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 Name: 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 Name: Menopur 600 IU




Primary Outcome Measures :
  1. Number of oocytes and mature oocytes [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Fertilization and implantation rates [ Time Frame: 3 months ]
  2. Drop-out rate and cancellation rate [ Time Frame: 3 months ]
  3. Cost-effectiveness analysis [ Time Frame: 6 months ]
  4. Endocrine profile in serum and follicular fluid [ Time Frame: 3 months ]
  5. Apoptosis rate in cumulus cells [ Time Frame: 6 months ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213627


Contacts
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Contact: Antonio Requena, MD, PhD +34 911802900 Antonio.Requena@ivi.es
Contact: María Cruz, PhD +34 911802900 Maria.Cruz@ivi.es

Locations
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Spain
IVI Madrid Recruiting
Madrid, Spain, 28023
Contact: Antonio Requena, MD, PhD    +34 911802900    Antonio.Requena@ivi.es   
Contact: María Cruz, PhD    +34 911802900    Maria.Cruz@ivi.es   
Principal Investigator: Antonio Requena, MD, PhD         
Sub-Investigator: María Cruz, PhD         
Sponsors and Collaborators
IVI Madrid
Instituto Valenciano de Infertilidad, IVI VALENCIA
Instituto Valenciano de Infertilidad, IVI Alicante
Investigators
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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

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Responsible Party: Antonio Requena, MD, PhD, IVI Madrid
ClinicalTrials.gov Identifier: NCT02213627     History of Changes
Other Study ID Numbers: 1403-MAD-013-AR
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by Antonio Requena, IVI Madrid:
Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female