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Clinical Trials/NCT02128360
NCT02128360
Unknown
Not Applicable

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

Sheba Medical Center1 site in 1 country200 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Letrozole, Gonadotropins
Conditions
Infertility
Sponsor
Sheba Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Clinical pregnancy rates
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
June 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of poor responder to ovarian stimulation

Exclusion Criteria

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

Arms & Interventions

Minimal stimulation protocol

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

Intervention: Letrozole, Gonadotropins

High dose protocol

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

Intervention: Gonadotropins

Outcomes

Primary Outcomes

Clinical pregnancy rates

Time Frame: 1 Year

Secondary Outcomes

  • Number of High quality embryos(1 year)
  • Number of eggs retrieved(1 year)

Study Sites (1)

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