Comparison of Triggers in Double Ovarian Stimulation (DuoStim).

Instituto Bernabeu165 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

IVF LOW OVARIAN RESPONSE

Interventions

Triptorelin acetate (a-GnRH)DRUG

Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.

Ovitrelle® (hCG)DRUG

Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.

Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used togetherDRUG

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.

Eligibility

Sex: FEMALEMin age: 28 YearsMax age: 43 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Instituto Bernabeu

Palma de Mallorca, Mallorca, Spain

RECRUITING

Instituto Bernabeu

Albacete, Spain

RECRUITING

Instituto Bernabeu

Alicante, Spain

RECRUITING

Outcomes

Primary Outcomes

number of retrieved oocytes

number of oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.

Time frame: through study completion, usually will be evaluated on the last day of the treatment

number of mature (MII) oocytes

number of mature (MII) oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.

Time frame: through study completion, usually will be evaluated on the last day of the treatment

Central Contacts

Anna Pitas, PhD

CONTACT

+34663926079 apitas@institutobernabeu.com

Data from ClinicalTrials.gov

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