Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 19, 2011
May 1, 2011
1 year
May 18, 2011
May 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy rates
One week
Study Arms (2)
Supplementary progesterone
ACTIVE COMPARATORWomen with mid-luteal progesterone levels that are less than 15 ng/dl will receive higher doses of supplementary progesterone
No additional progesterone
NO INTERVENTIONNo additional progesterone given to women with mid-luteal progesterone levels below 15 ng/dl
Interventions
The progesterone dose will be raised from 200 mg daily to 300 mg daily
Eligibility Criteria
You may qualify if:
- Mid-luteal serum progesterone levels below 15 ng/dl
You may not qualify if:
- Does not sign consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 19, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
May 19, 2011
Record last verified: 2011-05