Continuous Double Ovarian Stimulation.

May 1, 2025 updated by: Juan Carlos Castillo, Instituto Bernabeu

Continuous Ovarian Stimulation in DUOSTIM Cycles.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03016
        • Instituto Bernabeu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Drug: Corifollitropin Alfa
150 micrograms per dose
Other Names:
  • 4 Weekly Corifollitropin Alfa injections
Active Comparator: Control group
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).
Drug: Follitropin Alfa
Variable dose.
Other Names:
  • Daily injections of gonadotropins
Drug: Follitropin Alfa Biosimilar
Variable dose.
Other Names:
  • Daily injections of gonadotropins
Drug: Urinary Human follicle stimulating hormone
Variable dose.
Other Names:
  • Daily injections of gonadotropins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Retrieved Oocytes
Time Frame: 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).
Through study completion, an average of four weeks
Number of MII Oocytes
Time Frame: 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
Through study completion, an average of four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Ovarian Stimulation
Time Frame: Through study completion, an average of four months
Total days of follicular and luteal phases
Through study completion, an average of four months
Number of Injections
Time Frame: Through study completion, an average of four months
Number of injections during the DUOSTIM cycle
Through study completion, an average of four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Bernabeu

Investigators

  • Principal Investigator: Juan Carlos Castillo Farfan, MD, PhD, Instituto Bernabeu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBMR31
  • 2022-003177-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The PI will collect individual data which will later be analyzed. Only analyzed overall data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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