Early Follicular Supplementation of Ganirelix in IVF 2004
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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 |
- pregnancy rates [ Time Frame: one cycle ] [ Designated as safety issue: No ]
- 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 |
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| Israel | |
| The Baruch Padeh medical center, Poriya | |
| Tiberias, Israel, 15208 | |
| 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 May 21, 2013