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NCT00954811 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00954811
Other study ID # recombinant LH 1505
Secondary ID
Status Recruiting
Phase Phase 4
First received August 6, 2009
Last updated January 7, 2010
Start date September 2005
Est. completion date December 2010

Study information
Verified date August 2009
Source Universitair Ziekenhuis Brussel
Contact Evangelos Papanikolaou, PhD
Email drvagpapanikolaou@yahoo.gr
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2010
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 36 Years
Eligibility Inclusion Criteria:

- < 36years,

- single blastocystET,

- FSH < 12

Exclusion Criteria:

- endometriosis,

- 3 and 4,

- pco,

- frozen sperm

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• 300IU rec-LH
luteal alternate doses
• progesterone 600mg
luteal support

Locations
Country Name City State
Belgium Centre for Reproductive Medicine, UZ Brussel Brussels Jette

Sponsors (2)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel Merck Serono International SA

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy occurrence, pregnancy loss 14 days after OPU No
Secondary hormone levels, OHSS, endometrium 14 days after oocyte pick up No
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