Pregnancy Rates in IVF After Ovulation Triggering With Re... | NCT00954265

Studies
Pregnancy Rates in IVF After Ovulation Triggering With Recombinant or Urinary Human Chorionic Gonadotrophin (HCG)

NCT00954265

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Dec 24, 2009Estimated

Enrollment

130Estimated

Phase

Phase 3

Conditions

Embryonic Development
Pregnancy
VEGF

Interventions

10000 IU urinary HCG
250 mcg recombinant HCG

Countries

Belgium

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

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Dec 2007Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Aug 6, 2009

First Submission Date that Met QC Criteria

Aug 6, 2009

First Posted Date

Aug 7, 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

Dec 23, 2009

Last Update Posted Date

Dec 24, 2009Estimated

Name	Class
Merck Serono International SA	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on the blastulation rate and pregnancy rate of patients undergoing IVF treatment

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Urinary-HCG group	Active Comparator	These patients received u-HCG for ovulation triggering during ovarian stimulation for IVF	Drug: 10000 IU urinary HCG
Recombinant HCG group	Experimental	These patients received rec-HCG for ovulation triggering during ovarian stimulation for IVF	Drug: 250 mcg recombinant HCG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
10000 IU urinary HCG	Drug	ovulation triggering	Urinary-HCG group
250 mcg recombinant HCG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blastulation rate		on day-5

Secondary Outcomes

Measure	Description	Time Frame
pregnancy rates, VEGF levels, OHSS rate		14 days after oocyte pick up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

FSH<12,
normal sperm,less than 36y,
single blastocyst transfer

Exclusion Criteria:

endometriosis stage 3&4,
pco

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

36 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Devroey, Professor	Professor or OB-GYN	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Reproductive Medicine, UZ Brussel		Brussels	Jette	1090	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D006063	Chorionic Gonadotropin

Ancestor Terms

ID	Term
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided