Skip to main content
Clinical Trials/NCT05321511
NCT05321511
Unknown
Phase 4

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?

Instituto Bernabeu1 site in 1 country165 target enrollmentMarch 3, 2022

Overview

Phase
Phase 4
Intervention
Triptorelin acetate (a-GnRH)
Conditions
IVF
Sponsor
Instituto Bernabeu
Enrollment
165
Locations
1
Primary Endpoint
number of retrieved oocytes
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2022
End Date
March 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Instituto Bernabeu
Responsible Party
Principal Investigator
Principal Investigator

Andrea Bernabeu García

Co-Director

Instituto Bernabeu

Eligibility Criteria

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

Arms & Interventions

a-GnRH

Administration of triptorelin acetate 0.2 mg for final oocyte maturation.

Intervention: Triptorelin acetate (a-GnRH)

hCG

Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.

Intervention: Ovitrelle® (hCG)

a-GnRH + hCG

Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation.

Intervention: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

Loading locations...

Similar Trials