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

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ClinicalTrials.gov Identifier: NCT00954811
Recruitment Status : Unknown
Verified August 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : August 7, 2009
Last Update Posted : January 8, 2010
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by:
Universitair Ziekenhuis Brussel

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2005
Estimated Primary Completion Date : January 2008
Estimated Study Completion Date : December 2010

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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




Primary Outcome Measures :
  1. pregnancy occurrence, pregnancy loss [ Time Frame: 14 days after OPU ]

Secondary Outcome Measures :
  1. hormone levels, OHSS, endometrium [ Time Frame: 14 days after oocyte pick up ]


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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: August 2009

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action