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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02213627
Enrollment
300
Registered
2014-08-11
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Reproductive Problem, Infertility

Keywords

Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation

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)

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.

Interventions

DRUGCorifollitropin alfa
DRUGHP-hMG

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA
CollaboratorOTHER
Instituto Valenciano de Infertilidad, IVI Alicante
CollaboratorOTHER
IVI Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
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.

Design outcomes

Primary

MeasureTime frame
Number of oocytes and mature oocytes3 months

Secondary

MeasureTime frame
Fertilization and implantation rates3 months
Drop-out rate and cancellation rate3 months
Cost-effectiveness analysis6 months
Endocrine profile in serum and follicular fluid3 months
Apoptosis rate in cumulus cells6 months

Countries

Spain

Contacts

Primary ContactAntonio Requena, MD, PhD
Antonio.Requena@ivi.es+34 911802900
Backup ContactMaría Cruz, PhD
Maria.Cruz@ivi.es+34 911802900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026