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

October 12, 2010 updated by: Virginia Center for Reproductive Medicine

A Prospective Randomized Study of QD vs BID Dosing in ART

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Reston, Virginia, United States, 20190
        • Virginia Center for Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women between 21-40 yo

Description

Inclusion Criteria:

  • women < 40 undergoing ART

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
QD
Women who received their meds as QD administration
BID
Women who received their gonadotropins as a BID dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Center for Reproductive Medicine

Investigators

  • Principal Investigator: Fady I Sharara, M.D, Virginia Center for Reproductive Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 2010

Last Update Submitted That Met QC Criteria

October 12, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1-Sharara

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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