Endometrial Advancement After Rec or u-HCG Triggering

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Merck Serono International SA

Information provided by:

Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT00953628

First received: August 5, 2009

Last updated: September 1, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2009

Last Updated Date

September 1, 2009

Start Date ^ICMJE

August 2005

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

endometrium histology on the day of OPU [ Time Frame: day of oocytre pick up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00953628 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

pregnancy rate [ Time Frame: 14 days after oocyte pick up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endometrial Advancement After Rec or u-HCG Triggering

Official Title ^ICMJE

Endometrial Advancement After Rec or u-HCG Triggering

Brief Summary

The purpose of this study is to investigate any potential advantages of replacing human chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for final oocyte maturation with regard to Ovarian hyperstimulation syndrome (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Drug: 10000 IU urinary HCG
bolus 10000 units for ovulation triggering
Drug: 250 mcg recombinant HCG
bolus 250 mcg for ovulation triggering in IVF patients

Study Arm (s)

Active Comparator: o Group A=uHCG for triggering ovulation
Intervention: Drug: 10000 IU urinary HCG
Experimental: o Group B=recHCG for triggering ovulation
Intervention: Drug: 250 mcg recombinant HCG

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

130

Estimated Completion Date

December 2008

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Less than 36 years old
Male or tubal infertility
FSH<12 on day 3

Exclusion Criteria:

Endometriosis stage 3 & 4

Gender

Female

Ages

20 Years to 36 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00953628

Other Study ID Numbers ^ICMJE

recHCG001

Has Data Monitoring Committee

Responsible Party

Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel

Study Sponsor ^ICMJE

Universitair Ziekenhuis Brussel

Collaborators ^ICMJE

Merck Serono International SA

Investigators ^ICMJE

Study Director:

Paul Devroey, Professor

Professor or OB-GYN

Information Provided By

Universitair Ziekenhuis Brussel

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top