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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01356524
First received: May 18, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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 Intervention
Infertility
Drug: Additional vaginal progesterone

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

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Pregnancy rates [ Time Frame: One week ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Does not sign consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356524

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Nardin Aslih, MD    972-4-6304248    nardin_aslih@yahoo.com   
Principal Investigator: Nardin Aslih, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Nardin Aslih MD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01356524     History of Changes
Other Study ID Numbers: HYH-28-11
Study First Received: May 18, 2011
Last Updated: May 18, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014