Comparison of Triggers in Double Ovarian Stimulation (DuoStim).

Study Overview
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Brief Summary
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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.

Official Title
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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?

Conditions
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IVF, LOW OVARIAN RESPONSE

Intervention / Treatment
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* Drug: Triptorelin acetate (a-GnRH)
* Drug: Ovitrelle® (hCG)
* Drug: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: a-GnRH<br>Administration of triptorelin acetate 0.2 mg for final oocyte maturation. | Drug: Triptorelin acetate (a-GnRH)<br>* Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.<br>* Other names: Decapeptyl 0.1 mg®;|
| Active Comparator: hCG<br>Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation. | Drug: Ovitrelle® (hCG)<br>* Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.<br>|
| Experimental: a-GnRH + hCG<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of retrieved oocytes | 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 | 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 |