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Early Follicular Supplementation of Ganirelix in IVF 2004

Primary Purpose

Infertility, IVF Treatment

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Ganirelix
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, GnRH antagonist

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Baruch Padeh medical center, Poriya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle

Standard Flexible antagonist protocol

Outcomes

Primary Outcome Measures

pregnancy rates

Secondary Outcome Measures

differences in hormonal levels
differences in the basic treatment doses
oocyte counts
fertilization rate
cleavage rate

Full Information

First Posted
April 17, 2007
Last Updated
June 26, 2008
Sponsor
The Baruch Padeh Medical Center, Poriya
Collaborators
Organon
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1. Study Identification

Unique Protocol Identification Number
NCT00461422
Brief Title
Early Follicular Supplementation of Ganirelix in IVF 2004
Official Title
Early Follicular GnRH Antagonist Supplementation Improves Fertilization and Embryo Cleavage Rates in IVF-ET GnRH Antagonist Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Baruch Padeh Medical Center, Poriya
Collaborators
Organon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, IVF Treatment
Keywords
IVF, GnRH antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard Flexible antagonist protocol
Intervention Type
Drug
Intervention Name(s)
Ganirelix
Intervention Description
sc injection of Ganirelix 0.25 mg per day
Primary Outcome Measure Information:
Title
pregnancy rates
Time Frame
one cycle
Secondary Outcome Measure Information:
Title
differences in hormonal levels
Time Frame
one cycle
Title
differences in the basic treatment doses
Time Frame
one cycle
Title
oocyte counts
Time Frame
one cycle
Title
fertilization rate
Time Frame
one cycle
Title
cleavage rate
Time Frame
one cycle

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yohnny S Younis, MD
Organizational Affiliation
The Ministry of Health, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Baruch Padeh medical center, Poriya
City
Tiberias
ZIP/Postal Code
15208
Country
Israel

12. IPD Sharing Statement

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Early Follicular Supplementation of Ganirelix in IVF 2004

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