Early Follicular Supplementation of Ganirelix in IVF 2004

June 26, 2008 updated by: The Baruch Padeh Medical Center, Poriya

Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tiberias, Israel, 15208
        • The Baruch Padeh Medical Center, Poriya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rates
Time Frame: one cycle
one cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
differences in hormonal levels
Time Frame: one cycle
one cycle
differences in the basic treatment doses
Time Frame: one cycle
one cycle
oocyte counts
Time Frame: one cycle
one cycle
fertilization rate
Time Frame: one cycle
one cycle
cleavage rate
Time Frame: one cycle
one cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Organon

Investigators

  • Principal Investigator: Yohnny S Younis, MD, The Ministry of Health, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2008

Last Update Submitted That Met QC Criteria

June 26, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soltsman2004.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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