Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART) (QD vs BID)
This study has been completed.
Sponsor:
Virginia Center for Reproductive Medicine
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
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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
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 June 18, 2013