NCT00740025

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 14, 2010

Status Verified

October 1, 2010

Enrollment Period

4 years

First QC Date

August 21, 2008

Last Update Submit

October 12, 2010

Conditions

Pregnancy

Keywords

QD doseBID dosingpeak estradioloocytesimplantation ratepregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    1 year

Secondary Outcomes (1)

  • peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate

    1 year

Study Arms (2)

QD

Women who received their meds as QD administration

BID

Women who received their gonadotropins as a BID dose

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women between 21-40 yo

You may qualify if:

  • women \< 40 undergoing ART

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Center for Reproductive Medicine

Reston, Virginia, 20190, United States

Location

Study Officials

  • Fady I Sharara, M.D

    Virginia Center for Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2008

First Posted

August 22, 2008

Study Start

January 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 14, 2010

Record last verified: 2010-10

Locations

US(1)