Fixed Versus Flexible Gonadotropin-releasing Hormone (GnR... | NCT01005784

Studies
Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

NCT01005784

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

Nov 2, 2009Estimated

Enrollment

146Actual

Phase

Phase 4

Conditions

Subfertility

Interventions

Cetrorelix (Cetrotide)
Cetrorelix (Cetrotide)

Countries

Greece

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 2009

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

Jun 2005

Primary Completion Date

Jan 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Nov 13, 2007

First Submission Date that Met QC Criteria

Oct 30, 2009

First Posted Date

Nov 2, 2009Estimated

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 30, 2009

Last Update Posted Date

Nov 2, 2009Estimated

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 comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fixed	Active Comparator		Drug: Cetrorelix (Cetrotide)
flexible	Experimental		Drug: Cetrorelix (Cetrotide)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetrorelix (Cetrotide)	Drug	flexible antagonist administration according to specified criteria	flexible

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Luteinizing hormone rise		3-14 days (duration of ovarian stimulation)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

< 39 years of age
BMI 18.5-29.9
<= 3 previous IVF cycles

Exclusion Criteria:

PCOS
Endometriosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Efstratios Kolibianakis	Unit for Human Reproduction	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unit for Human Reproduction		Thessaloniki			Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20637457	Derived	Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases