Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve

Study Overview
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Brief Summary
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The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.

Detailed Description
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A prospective randomized trial will be carried out. The Minimal stimulation (MS) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. GnRH antagonist wil be introduced to avoid premature LH surge when one or more of the growing follicles reached approximately 14 mm in size. The high dose stimulation protocol is based on high dose of gonadotropins (≥300 IU/day) throughout the cycle with the usage of gonadotropin-releasing hormone (GnRH) antagonist to avoid premature luteinizing hormone (LH) surge as described above.

Official Title
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Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve

Conditions
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Infertility

Intervention / Treatment
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* Drug: Letrozole, Gonadotropins
* Drug: Gonadotropins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of poor responder to ovarian stimulation Exclusion Criteria: Patients undergoing pregestational diagnosis (PGD) Patients using donor eggs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Minimal stimulation protocol<br>Low dose Letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the Letrozole at 150 units per day. GnRH antagonist to avoid premature LH surge will be introduced when one or more of the growing follicles reached approximately 14 mm in size | Drug: Letrozole, Gonadotropins<br> <br> |
| Active Comparator: High dose protocol<br>High dose of gonadotropins (≥300 IU/day) starting from cycle day 3. GnRH antagonist will be introduced to avoid premature LH surge when one or more of the growing follicles will reach approximately 14 mm in size | Drug: Gonadotropins<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rates |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of High quality embryos | How many embryos of 6-8 cells with low fragmentation in each arm | 1 year | 
| Number of eggs retrieved |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low ovarian reserve, Poor responder, Infertility