Continuous Double Ovarian Stimulation.

Phase 4

Completed

• Conditions: Fertility Issues
• Interventions: Drug: Follitropin Alfa; Drug: Corifollitropin Alfa; Drug: Follitropin Alfa Biosimilar; Drug: Urinary Human follicle stimulating hormone

• Registration Number: NCT05815719
• Lead Sponsor: Instituto Bernabeu

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-11-17
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-30
• Results First Submitted: 2023-12-23
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Results First Posted: 2025-05-18
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Follitropin Alfa Biosimilar	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).
Control group	Urinary Human follicle stimulating hormone	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).
Control group	Follitropin Alfa	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).
Study group	Corifollitropin Alfa	Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.

Primary Outcome Measures

Name	Time	Method
Total Number of Retrieved Oocytes	Through study completion, an average of four weeks	To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation cycles (DUOSTIM) utilizing weekly subcutaneous injections of Corifollitropin alfa (study group) vs. daily injections of gonadotropins (control group).
Number of MII Oocytes	Through study completion, an average of four months	To compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups

Secondary Outcome Measures

Name	Time	Method
Duration of Ovarian Stimulation	Through study completion, an average of four months	Total days of follicular and luteal phases
Number of Injections	Through study completion, an average of four months	Number of injections during the DUOSTIM cycle

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Alicante, Spain