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

Instituto Bernabeu

Status and phase: Unknown; Phase 4

Conditions: IVF; LOW OVARIAN RESPONSE

Treatments: Drug: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together; Drug: Ovitrelle® (hCG); Drug: Triptorelin acetate (a-GnRH)

Study type: Interventional

Funder types: Other

Identifiers

NCT05321511

IB-0121

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: Female

Ages: 28 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 3 patient groups

a-GnRH

Active Comparator group

Description:

Administration of triptorelin acetate 0.2 mg for final oocyte maturation.

Treatment:

Drug: Triptorelin acetate (a-GnRH)

hCG

Active Comparator group

Description:

Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.

Treatment:

Drug: Ovitrelle® (hCG)

a-GnRH + hCG

Experimental group

Description:

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

Treatment:

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