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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00954811
First received: August 6, 2009
Last updated: January 7, 2010
Last verified: August 2009

August 6, 2009
January 7, 2010
September 2005
January 2008   (final data collection date for primary outcome measure)
pregnancy occurrence, pregnancy loss [ Time Frame: 14 days after OPU ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00954811 on ClinicalTrials.gov Archive Site
hormone levels, OHSS, endometrium [ Time Frame: 14 days after oocyte pick up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Pregnancy
  • Pregnancy Loss
  • Drug: 300IU rec-LH
    luteal alternate doses
  • Drug: progesterone 600mg
    luteal support
  • Active Comparator: HCG for ovulation triggering and luteal progesterone
    conventional triggering with HCG and conventional luteal support with progesterone
    Intervention: Drug: progesterone 600mg
  • 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
    Intervention: Drug: 300IU rec-LH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2010
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • < 36years,
  • single blastocystET,
  • FSH < 12

Exclusion Criteria:

  • endometriosis,
  • 3 and 4,
  • pco,
  • frozen sperm
Female
20 Years to 36 Years
No
Contact: Evangelos Papanikolaou, PhD drvagpapanikolaou@yahoo.gr
Belgium
 
NCT00954811
recombinant LH 1505
Yes
Dr Papanikolaou Evangelos, Centre for Reproductive Medicine,UZ Brussel
Universitair Ziekenhuis Brussel
Merck Serono International SA
Study Chair: Paul Devroey Professor or OB-GYN
Universitair Ziekenhuis Brussel
August 2009

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