Continuous Double Ovarian Stimulation.

Instituto Bernabeu

Status and phase: Completed; Phase 4

Conditions: Fertility Issues

Treatments: Drug: Follitropin Alfa Biosimilar; Drug: Follitropin Alfa; Drug: Urinary Human follicle stimulating hormone; Drug: Corifollitropin Alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT05815719

IBMR31

2022-003177-32 (EudraCT Number)

Details and patient eligibility

About

To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.

Full description

The purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (DUOSTIM) and in comparison with the conventional DUOSTIM protocol: daily administration of gonadotropins.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with indication for DUOSTIM protocol
• Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process.
• Ability to participate and comply with the study protocol.
• To have given written consent

Exclusion criteria

• Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts.
• Concurrent participation in another study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Study group

Experimental group

Description:

Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.

Treatment:

Drug: Corifollitropin Alfa

Control group

Active Comparator group

Description:

Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic).

Treatment:

Drug: Urinary Human follicle stimulating hormone

Drug: Follitropin Alfa

Drug: Follitropin Alfa Biosimilar