Use of Corifolitropin Alfa in Oocyte Donors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Female Reproductive Problem Infertility||Drug: Corifollitropin alfa Drug: Recombinant FSH Drug: HP-hMG||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
Other Name: Menopur 600 IU
- Number of oocytes and mature oocytes [ Time Frame: 3 months ]
- Fertilization and implantation rates [ Time Frame: 3 months ]
- Drop-out rate and cancellation rate [ Time Frame: 3 months ]
- Cost-effectiveness analysis [ Time Frame: 6 months ]
- Endocrine profile in serum and follicular fluid [ Time Frame: 3 months ]
- Apoptosis rate in cumulus cells [ Time Frame: 6 months ]
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
|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||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|