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NCT01356524 Clinical Trial

Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)

Infertility Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01356524
Other study ID # HYH-28-11
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 18, 2011
Last updated May 18, 2011
Start date July 2011
Est. completion date July 2012

Study information
Verified date May 2011
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 160
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Mid-luteal serum progesterone levels below 15 ng/dl

Exclusion Criteria:

- Does not sign consent form

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Additional vaginal progesterone
The progesterone dose will be raised from 200 mg daily to 300 mg daily

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy rates One week No
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