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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
History of Changes
  Purpose

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 Intervention Phase
Pregnancy
Pregnancy Loss
 Drug: 300IU rec-LH
Drug: progesterone 600mg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • pregnancy occurrence, pregnancy loss [ Time Frame: 14 days after OPU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hormone levels, OHSS, endometrium [ Time Frame: 14 days after oocyte pick up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • endometriosis,
  • 3 and 4,
  • pco,
  • frozen sperm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954811

Contacts
Contact: Evangelos Papanikolaou, PhD drvagpapanikolaou@yahoo.gr

Locations
Belgium
Centre for Reproductive Medicine, UZ Brussel Recruiting
Brussels, Jette, Belgium, 1090
Contact: Evangelos Papanikolaou, MD,PhD     0032 2 4776606     drvagpapanikolaou@yahoo.gr    
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Merck Serono International SA
Investigators
Study Chair: Paul Devroey Professor or OB-GYN
  More Information

Additional Information:
main web page of the centre for reproductive medicine in UZ Brussels  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Papanikolaou Evangelos, Centre for Reproductive Medicine,UZ Brussel
ClinicalTrials.gov Identifier: NCT00954811     History of Changes
Other Study ID Numbers: recombinant LH 1505
Study First Received: August 6, 2009
Last Updated: January 7, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
pregnancy

Additional relevant MeSH terms:
Progesterone
Deslorelin
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013