Back to resultsComparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Letrozole, Gonadotropins
Gonadotropins
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Low ovarian reserve, Poor responder, Infertility
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of poor responder to ovarian stimulation
Exclusion Criteria:
- Patients undergoing pregestational diagnosis (PGD)
- Patients using donor eggs
Sites / Locations
- The Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Minimal stimulation protocol
High dose protocol
Arm Description
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 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
Outcomes
Primary Outcome Measures
Clinical pregnancy rates
Secondary Outcome Measures
Number of High quality embryos
How many embryos of 6-8 cells with low fragmentation in each arm
Number of eggs retrieved
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02128360
Brief Title
Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve
Official Title
Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Low ovarian reserve, Poor responder, Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minimal stimulation protocol
Arm Type
Active Comparator
Arm Description
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
Arm Title
High dose protocol
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Letrozole, Gonadotropins
Intervention Type
Drug
Intervention Name(s)
Gonadotropins
Primary Outcome Measure Information:
Title
Clinical pregnancy rates
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Number of High quality embryos
Description
How many embryos of 6-8 cells with low fragmentation in each arm
Time Frame
1 year
Title
Number of eggs retrieved
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of poor responder to ovarian stimulation
Exclusion Criteria:
Patients undergoing pregestational diagnosis (PGD)
Patients using donor eggs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shir Dar, MD
Email
dr.shirdar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shir Dar, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve
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