Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART) (QD vs BID)

This study has been completed.
Sponsor:
Information provided by:
Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT00740025
First received: August 21, 2008
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

This is a prospective randomized study evaluating dosing frequency of gonadotropin administration in ART cycles.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Randomized Study of QD vs BID Dosing in ART

Further study details as provided by Virginia Center for Reproductive Medicine:

Primary Outcome Measures:
  • Ongoing pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
QD
Women who received their meds as QD administration
BID
Women who received their gonadotropins as a BID dose

Detailed Description:

Using once daily or bid dosing of gonadotropins in ART has been arbitrary with no studies showing whether splitting the medication dose improves ART parameters. This study was undertaken to provide an answer to this important question.

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women between 21-40 yo

Criteria

Inclusion Criteria:

  • women < 40 undergoing ART

Exclusion Criteria:

  • women > 40
  • endometriomas
  • severe cervical stenosis
  • testicular sperm
  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: NCT00740025

Locations
United States, Virginia
Virginia Center for Reproductive Medicine
Reston, Virginia, United States, 20190
Sponsors and Collaborators
Virginia Center for Reproductive Medicine
Investigators
Principal Investigator: Fady I Sharara, M.D Virginia Center for Reproductive Medicine
  More Information

No publications provided

Responsible Party: Fady I. Sharara, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT00740025     History of Changes
Other Study ID Numbers: 1-Sharara
Study First Received: August 21, 2008
Last Updated: October 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Center for Reproductive Medicine:
QD dose
BID dosing
peak estradiol
oocytes
implantation rate
pregnancy rate

ClinicalTrials.gov processed this record on September 30, 2014