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Completed

NCT Number: NCT00461422

Early Follicular Supplementation of Ganirelix in IVF 2004

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

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Key information

Conditions

Infertility Genital Diseases IVF Treatment Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Baruch Padeh medical center, Poriya

Tiberias, 15208, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganirelix

Drug

sc injection of Ganirelix 0.25 mg per day

Primary outcomes

  1. pregnancy rates

    Time frame: one cycle

Secondary outcomes

  1. differences in hormonal levels

    Time frame: one cycle

  2. differences in the basic treatment doses

    Time frame: one cycle

  3. oocyte counts

    Time frame: one cycle

  4. fertilization rate

    Time frame: one cycle

  5. cleavage rate

    Time frame: one cycle

Sponsors and collaborators

Lead sponsor

The Baruch Padeh Medical Center, Poriya

Other Gov

Collaborators

  • Organon

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Apr 18, 2007
Registry last updated
Jun 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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