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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356524
Recruitment Status : Unknown
Verified May 2011 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 19, 2011
Last Update Posted : May 19, 2011
Information provided by:
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Additional vaginal progesterone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Supplementary progesterone
Women with mid-luteal progesterone levels that are less than 15 ng/dl will receive higher doses of supplementary progesterone
Drug: Additional vaginal progesterone
The progesterone dose will be raised from 200 mg daily to 300 mg daily
No Intervention: No additional progesterone
No additional progesterone given to women with mid-luteal progesterone levels below 15 ng/dl

Primary Outcome Measures :
  1. Pregnancy rates [ Time Frame: One week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Does not sign consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356524

Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Nardin Aslih, MD    972-4-6304248   
Principal Investigator: Nardin Aslih, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Nardin Aslih MD, Hillel Yaffe Medical Center Identifier: NCT01356524     History of Changes
Other Study ID Numbers: HYH-28-11
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs