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

Not Applicable

• Conditions: Infertility
• Interventions: Drug: Letrozole, Gonadotropins; Drug: Gonadotropins

• Registration Number: NCT02128360
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-23
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20
• Study Start: 2015-03
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Clinical diagnosis of poor responder to ovarian stimulation

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Exclusion Criteria

• Patients undergoing pregestational diagnosis (PGD)
• Patients using donor eggs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal stimulation protocol	Letrozole, Gonadotropins	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
High dose protocol	Gonadotropins	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

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rates	1 Year

Secondary Outcome Measures

Name	Time	Method
Number of High quality embryos	1 year	How many embryos of 6-8 cells with low fragmentation in each arm
Number of eggs retrieved	1 year

Trial Locations

Locations (1)

The Chaim Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel