Comparison of Triggers in Double Ovarian Stimulation (DuoStim). (COTRID)

April 4, 2022 updated by: Andrea Bernabeu García, Instituto Bernabeu

Double Ovarian Stimulation (DuoStim) Comparison of Triggers: Is There Any Advantage Using 3 Different Methods of Trigger for the Second Egg Collection in Predicted Low Responders?

This study aims to investigate the efficacy of 3 different trigggers used for final maturation in the second ovarian stimulation in double stimulation protocol (aGnRH and hCG-rec vs. aGnRH only vs. hCG-rec only). The main objective is to compare the number of all retrieved oocytes and mature oocytes in patients predicted to be low ovarian responders.

This is a controlled randomized clinical study where 165 patients will be recruited.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

165

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 Contact

Study Locations

  • Spain
      • Albacete, Spain, 02005
        • Recruiting
        • Instituto Bernabeu
        • Contact:
        • Principal Investigator:
          • Lydia Luque, Dr.
      • Alicante, Spain, 03016
        • Recruiting
        • Instituto Bernabeu
        • Contact:
        • Principal Investigator:
          • Andrea Bernabeu, Dr.
      • Madrid, Spain, 28001
        • Recruiting
        • Instituto Bernabeu
        • Contact:
        • Principal Investigator:
          • Ruth Romero, Dr.
    • Mallorca
      • Palma De Mallorca, Mallorca, Spain, 07006
        • Recruiting
        • Instituto Bernabeu
        • Contact:
        • Principal Investigator:
          • Jordi Suñol, Dr.

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

28 years to 43 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI below 32
  • Presence of both ovaries
  • Indication for ovarian stimulation under Double Stimulation protocol (Duo Stim)
  • Meeting the criteria for Duo Stim
  • Medical history, history and physical examination without alterations
  • AMH and AFV results in accordnace to Poseidon classification group 3 or 4 no more than 6 months prior to signing the consent form
  • Ability to participate and comply with the study protocol.
  • To have given written consent
  • Normal karyotype and fragile X.

Exclusion Criteria:

  • Non-compliance with instructions and/or non-formalization of consents or legal requirements for IVF.
  • 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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: a-GnRH
Administration of triptorelin acetate 0.2 mg for final oocyte maturation.
Drug: Triptorelin acetate (a-GnRH)
Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
Other Names:
  • Decapeptyl 0.1 mg®
ACTIVE_COMPARATOR: hCG
Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.
Drug: Ovitrelle® (hCG)
Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
EXPERIMENTAL: a-GnRH + hCG
Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation.
Drug: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together
Adminsitration of triptoreline acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of retrieved oocytes
Time Frame: through study completion, usually will be evaluated on the last day of the treatment
number of oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
through study completion, usually will be evaluated on the last day of the treatment
number of mature (MII) oocytes
Time Frame: through study completion, usually will be evaluated on the last day of the treatment
number of mature (MII) oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
through study completion, usually will be evaluated on the last day of the treatment

Collaborators and Investigators

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

Sponsor

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)

March 3, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

March 31, 2023

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (ACTUAL)

April 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB-0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on IVF

Clinical Trials on Triptorelin acetate (a-GnRH)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe