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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03939403
Other study ID # IB-0319-002
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 18, 2019
Est. completion date May 8, 2021

Study information

Verified date May 2021
Source Instituto Bernabeu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation). This a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date May 8, 2021
Est. primary completion date May 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 32 Years
Eligibility Inclusion Criteria: - Eligible for oocyte donation program - Age between 18 and 32 years old - BMI >18 and <30 - Antral follicle count >12 (summing both ovaries) - Presence of both ovaries - Ability to participate in and comply with study protocol - Signed informed consent - No treatment with ovulation stimulators in the 3 months prior to the start of stimulation. Exclusion Criteria: - Diagnosis of endometriosis at any stage - AFC >20 - Polycystic ovary syndrome - Concurrent participation in another study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Time of administration of Corifollitropin Alfa
The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use.

Locations

Country Name City State
Spain Instituto Bernabeu Alicante

Sponsors (1)

Lead Sponsor Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of oocytes Number of oocytes after stimulation At the end of stimulation
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