Comparison of Triggers in Double Ovarian Stimulation (DuoStim).

Phase 4

• Conditions: IVF; LOW OVARIAN RESPONSE
• Interventions: Drug: Ovitrelle® (hCG); Drug: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together; Drug: Triptorelin acetate (a-GnRH)

• Registration Number: NCT05321511
• Lead Sponsor: Instituto Bernabeu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-03
• Study First Submitted: 2022-03-24
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-04
• Last Update Submitted: 2022-04-04
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hCG	Ovitrelle® (hCG)	Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.
a-GnRH + hCG	Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together	Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation.
a-GnRH	Triptorelin acetate (a-GnRH)	Administration of triptorelin acetate 0.2 mg for final oocyte maturation.

Primary Outcome Measures

Name	Time	Method
number of mature (MII) oocytes	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.
number of retrieved oocytes	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.

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Madrid, Spain