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Early Follicular Supplementation of Ganirelix in IVF 2004

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00461422
Enrollment
50
Registered
2007-04-18
Start date
2004-01-31
Completion date
2007-06-30
Last updated
2008-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, IVF Treatment

Keywords

IVF, GnRH antagonist

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.

Interventions

DRUGGanirelix

sc injection of Ganirelix 0.25 mg per day

Sponsors

Organon
CollaboratorINDUSTRY
The Baruch Padeh Medical Center, Poriya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frame
pregnancy ratesone cycle

Secondary

MeasureTime frame
differences in hormonal levelsone cycle
differences in the basic treatment dosesone cycle
oocyte countsone cycle
fertilization rateone cycle
cleavage rateone cycle

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026