Early Follicular Supplementation of Ganirelix in IVF 2004

Baruch Padeh Medical Center

Status and phase: Completed; Phase 4

Conditions: Infertility; IVF Treatment

Treatments: Drug: Ganirelix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00461422

soltsman2004.CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Ganirelix

2

No Intervention group

Description:

Standard Flexible antagonist protocol