A Phase 4 interventional study of Corifollitropin alfa and Recombinant FSH in Female Reproductive Problem and Infertility, sponsored by IVI Madrid. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-17.
Sponsored by IVI Madrid · Phase 4, Interventional, and Treatment
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)
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
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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
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
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
Also known as: Elonva 100 micrograms
Also known as: Puregon 50 IU
Also known as: 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
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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IVI Madrid