Once Daily vs Twice Daily Administration of Gonadotropins... | NCT00740025

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

NCT00740025

Sponsor

Virginia Center for Reproductive Medicine

Status

Completed

Last Update Posted

Oct 14, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Aug 21, 2008

First Submission Date that Met QC Criteria

Aug 21, 2008

First Posted Date

Aug 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2010

Last Update Posted Date

Oct 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QD		Women who received their meds as QD administration
BID		Women who received their gonadotropins as a BID dose

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy		1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women < 40 undergoing ART

Exclusion Criteria:

women > 40
endometriomas
severe cervical stenosis
testicular sperm

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Women between 21-40 yo

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fady I Sharara, M.D	Virginia Center for Reproductive Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Center for Reproductive Medicine		Reston	Virginia	20190	United States