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Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

NCT02084940 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2014-03-12

No results posted yet for this study

Summary

PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.

Conditions

  • Polycystic Ovarian Syndrome
  • Ovarian Hyperstimulation Syndrome
  • Invitro Fertilization

Interventions

DRUG

GnRH antagonist depot Degarelix

Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering

Sponsors & Collaborators

  • Bioroma

    lead OTHER

Eligibility

Min Age
23 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02084940 on ClinicalTrials.gov