Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART) - Full Text View

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

This study is currently recruiting participants.

Verified by Virginia Center for Reproductive Medicine, August 2008

Sponsored by:	Virginia Center for Reproductive Medicine
Information provided by:	Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:	NCT00740025

Purpose

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

Condition
Pregnancy

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (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

Contacts

Contact: Fady I Sharara, M.D

7034377722

fsharara@vcrmed.com

Locations

United States, Virginia
Virginia Center for Reproductive Medicine	Recruiting
Reston, Virginia, United States, 20190
Contact: Fady I Sharara, M.D 703-437-7722 fsharara@vcrmed.com

Sponsors and Collaborators

Virginia Center for Reproductive Medicine

More Information

Responsible Party:	Virginia Center for Reproductive Medicine ( Fady I. Sharara )
Study ID Numbers:	1-Sharara
Study First Received:	August 21, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740025
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

Study placed in the following topic categories:

Estradiol 3-benzoate
Estradiol valerate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

ClinicalTrials.gov processed this record on January 16, 2009