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A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)

This study is currently recruiting participants.
Verified December 2012 by Virginia Center for Reproductive Medicine
Sponsor:
Information provided by (Responsible Party):
Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT01139593
First received: June 6, 2010
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Randomized Trial Comparing Qam With Qpm Daily Dosing in Assisted Reproductive Technologies

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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

Primary Outcome Measures:
  • Live birth rate [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
morning dose
women undergoing IVF/ICSi taking their gonadotropin dose in the am
evening dose
Women undergoing IVF/ICSI taking their gonadotropin in the evening

  Eligibility

Ages Eligible for Study:   21 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Infertile women between 21 and 44 years old

Criteria

Inclusion Criteria:

  • women between 21-42 undergoing IVF

Exclusion Criteria:

  • women > 45,
  • women with one ovary,
  • donor egg,
  • surrogacy,
  • FET cycles,
  • uterine problems,
  • large fibroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139593

Contacts
Contact: Fady Sharara, M.D 7034377722 fsharara@vcrmed.com

Locations
United States, Virginia
Virginia Center for Reproductive Medicine Recruiting
Reston, Virginia, United States, 20190
Contact: Fady Sharara, M.D     703-437-7722     info@vcrmed.com    
Principal Investigator: Fady Sharara, M.D            
Sponsors and Collaborators
Virginia Center for Reproductive Medicine
  More Information

No publications provided

Responsible Party: Fady I. Sharara, M.D, Medical Director, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT01139593     History of Changes
Other Study ID Numbers: VCRM 5
Study First Received: June 6, 2010
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Center for Reproductive Medicine:
IVF
ICSI
gonadotropin
am dose
 pm dose
pregnancy
implantation
live birth

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 17, 2013