A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of two new patterns of controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study will be performed in egg donors but these new patterns will be implemented in fertility preservation patients.

Official Title
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A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

Conditions
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Stimulation in the Ovary

Intervention / Treatment
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* Procedure: Early luteal phase
* Procedure: Late follicular phase -COH-


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premenopausal women 18-30 years old, with FSH levels < 10mIU irregular menstrual cycle BMI between 12-28 signed inform consent Exclusion Criteria: Polycystic ovarian syndrome, gonadotropins allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early luteal phase -COH-<br>We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the early luteal phase. | Procedure: Early luteal phase<br>* We will administer in the tenth day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.<br>|
| Active Comparator: Late folicular phase - COH -<br>We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the late follicular phase. | Procedure: Late follicular phase -COH-<br>* We will administer in the 20th day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eggs | The results will be presented in one year, egg recipients will be followed until 12 weeks of pregnancy. | Participants will be followed after 1-3 hrs of follicular aspiration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metaphase II, Ovarian stimulation, Egg donors