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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Unknown status

CT.gov ID

NCT00954811

Collaborator

Merck Serono International SA (Industry)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Pregnancy Loss	Drug: 300IU rec-LH Drug: progesterone 600mg	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase IV Study on the Effect of Luteal Supplementation With Rec-LH on the Pregnancy Rate After Ovulation Triggering With GnRH-agonist Instead of HCG in IVF Protocol;Proof of Concept

Study Start Date :

Sep 1, 2005

Anticipated Primary Completion Date :

Jan 1, 2008

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HCG for ovulation triggering and luteal progesterone conventional triggering with HCG and conventional luteal support with progesterone	Drug: progesterone 600mg luteal support
Experimental: Agonist triggering and rec-LH luteal support plus progesterone 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 luteal alternate doses

Arm

Intervention/Treatment

Active Comparator: HCG for ovulation triggering and luteal progesterone

conventional triggering with HCG and conventional luteal support with progesterone

Drug: progesterone 600mg

luteal support

Experimental: Agonist triggering and rec-LH luteal support plus progesterone

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

luteal alternate doses

Outcome Measures

Primary Outcome Measures

pregnancy occurrence, pregnancy loss [14 days after OPU]

Secondary Outcome Measures

hormone levels, OHSS, endometrium [14 days after oocyte pick up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 36 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

< 36years,
single blastocystET,
FSH < 12

Exclusion Criteria:

endometriosis,
3 and 4,
pco,
frozen sperm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Reproductive Medicine, UZ Brussel	Brussels	Jette	Belgium	1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel
Merck Serono International SA

Investigators

Study Chair: Paul Devroey, Professor or OB-GYN

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

main web page of the centre for reproductive medicine in UZ Brussels

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00954811

Other Study ID Numbers:

recombinant LH 1505

First Posted:

Aug 7, 2009

Last Update Posted:

Jan 8, 2010

Last Verified:

Aug 1, 2009

Keywords provided by , ,

pregnancy

Additional relevant MeSH terms:

Progesterone

Study Results

No Results Posted as of Jan 8, 2010