Back to resultsRelationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Additional vaginal progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Mid-luteal serum progesterone levels below 15 ng/dl
Exclusion Criteria:
- Does not sign consent form
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Supplementary progesterone
No additional progesterone
Arm Description
Women with mid-luteal progesterone levels that are less than 15 ng/dl will receive higher doses of supplementary progesterone
No additional progesterone given to women with mid-luteal progesterone levels below 15 ng/dl
Outcomes
Primary Outcome Measures
Pregnancy rates
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01356524
Brief Title
Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In Assisted Reproductive Techniques (ART) there is a need for luteal support using progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of administration and dose has not yet been determined.
The aim of the study is to investigate whether high levels of mid-luteal serum progesterone are related to higher pregnancy rates in ART cycles. We also plan to investigate whether using higher doses of vaginal progesterone results in higher pregnancy rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supplementary progesterone
Arm Type
Active Comparator
Arm Description
Women with mid-luteal progesterone levels that are less than 15 ng/dl will receive higher doses of supplementary progesterone
Arm Title
No additional progesterone
Arm Type
No Intervention
Arm Description
No additional progesterone given to women with mid-luteal progesterone levels below 15 ng/dl
Intervention Type
Drug
Intervention Name(s)
Additional vaginal progesterone
Intervention Description
The progesterone dose will be raised from 200 mg daily to 300 mg daily
Primary Outcome Measure Information:
Title
Pregnancy rates
Time Frame
One week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mid-luteal serum progesterone levels below 15 ng/dl
Exclusion Criteria:
Does not sign consent form
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nardin Aslih, MD
Phone
972-4-6304248
Email
nardin_aslih@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nardin Aslih, MD
12. IPD Sharing Statement
Learn more about this trial
Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)
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