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

This study has been completed.
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 8, 2015
Last verified: December 2015
  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

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 ]

Enrollment: 128
Study Start Date: June 2010
Study Completion Date: December 2015
Primary Completion Date: November 2015 (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   (Adult)
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
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: NCT01139593

Locations
United States, Virginia
Virginia Center for Reproductive Medicine
Reston, Virginia, United States, 20190
Sponsors and Collaborators
Virginia Center for Reproductive Medicine
  More Information

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 8, 2015
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 September 26, 2016