Early Follicular Supplementation of Ganirelix in IVF 2004

This study has been completed.
Sponsor:
Collaborator:
Organon
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT00461422
First received: April 17, 2007
Last updated: June 26, 2008
Last verified: June 2008
  Purpose

Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results


Condition Intervention Phase
Infertility
IVF Treatment
Drug: Ganirelix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles

Resource links provided by NLM:


Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • pregnancy rates [ Time Frame: one cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • differences in hormonal levels [ Time Frame: one cycle ] [ Designated as safety issue: No ]
  • differences in the basic treatment doses [ Time Frame: one cycle ] [ Designated as safety issue: No ]
  • oocyte counts [ Time Frame: one cycle ] [ Designated as safety issue: No ]
  • fertilization rate [ Time Frame: one cycle ] [ Designated as safety issue: No ]
  • cleavage rate [ Time Frame: one cycle ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle
Drug: Ganirelix
sc injection of Ganirelix 0.25 mg per day
No Intervention: 2
Standard Flexible antagonist protocol

Detailed Description:

GnRH antagonist offers many advantages when used in IVF-ET treatment, however, it is suspected to yield lower pregnancy rate when compared with the long GnRH agonist protocol.

Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results.

Consecutive patients are prospectively enrolled and randomly assigned to the study and control groups. Patients with low ovarian reserve or with uterine distortion are excluded from the study. Both groups are treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group are also treated with additional GnRH antagonist 0.25 mg/day on day 1, 2 and 3 of the menstrual cycle.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertility
  • IVF candidate
  • failure of previous IVF attempt

Exclusion Criteria:

  • low ovarian reserve
  • untreated distortion of uterine cavity
  • medical contraindication for IVF treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00461422

Locations
Israel
The Baruch Padeh medical center, Poriya
Tiberias, Israel, 15208
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Organon
Investigators
Principal Investigator: Yohnny S Younis, MD The Ministry of Health, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00461422     History of Changes
Other Study ID Numbers: soltsman2004.CTIL
Study First Received: April 17, 2007
Last Updated: June 26, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by The Baruch Padeh Medical Center, Poriya:
IVF
GnRH antagonist

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014