Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor

NCT ID: NCT03939403

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-05-08

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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7-days pill free interval

Group Type EXPERIMENTAL

Time of administration of Corifollitropin Alfa

Intervention Type DRUG

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.

5-days pill free interval

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

32 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Bernabeu

OTHER

Sponsor Role lead

Responsible Party

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Joaquín Llácer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Bernabeu

Alicante, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IB-0319-002

Identifier Type: -

Identifier Source: org_study_id

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