Luteal Supplementation With Rec-LH After GnRH-agonist Tri... | NCT00954811

Studies
Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)

NCT00954811

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Jan 8, 2010Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Pregnancy
Pregnancy Loss

Interventions

300IU rec-LH
progesterone 600mg

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

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jan 2008Estimated

Completion Date

Dec 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

Jan 7, 2010

Last Update Posted Date

Jan 8, 2010Estimated

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

Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.

Detailed Description

Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCG for ovulation triggering and luteal progesterone	Active Comparator	conventional triggering with HCG and conventional luteal support with progesterone	Drug: progesterone 600mg
Agonist triggering and rec-LH luteal support plus progesterone	Experimental	new method of triggering with GnRH-agonist and proof of concept intervention with novel way of luteal support with rec-LH plus the usual co-treatment with progesterone	Drug: 300IU rec-LH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
300IU rec-LH	Drug	luteal alternate doses	Agonist triggering and rec-LH luteal support plus progesterone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy occurrence, pregnancy loss		14 days after OPU

Secondary Outcomes

Measure	Description	Time Frame
hormone levels, OHSS, endometrium		14 days after oocyte pick up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

< 36years,
single blastocystET,
FSH < 12

Exclusion Criteria:

endometriosis,
3 and 4,
pco,
frozen sperm

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

Name	Role	Phone	Extension	Email
Evangelos Papanikolaou, PhD	Contact			drvagpapanikolaou@yahoo.gr

Overall Officials

Name	Affiliation	Role
Paul Devroey	Professor or OB-GYN	Study Chair

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D011374	Progesterone

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided