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Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF


Phase 3
20 Years
38 Years
Open (Enrolling)
Female
PCOS, OHSS, INFERTILITY

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Trial Information

Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF


Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For
this reason in this study the degarelix was tested in order to minimize the risk of OHSS as
well as to improve the pregnancy rate in these patients. The use of long acting GnRH
antagonist promotes a deep suppression of LH and consequently the activity of theca cells,
which secrete androgens (the precursors of estradiol), and consequently the levels of
estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle
with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in
order to establish the best way to perform controlled hyperstimulation in IVF cycles and
minimize the risk of OHSS.


Inclusion Criteria:



- women with PCOS

- previous OHSS

- Infertility

Exclusion Criteria:

- more than 38 years old

- Body mass index pore than 30

- other systemic diseases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

PREGNANCY RATE

Outcome Description:

number of ongoing pregnancy obtained in the group

Outcome Time Frame:

6 MONTHS

Safety Issue:

No

Principal Investigator

Marco Sbracia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre for Endocrinology and Reproductive Medicine, Italy

Authority:

Italy: Ministry of Health

Study ID:

C05

NCT ID:

NCT01709942

Start Date:

November 2012

Completion Date:

May 2013

Related Keywords:

  • PCOS
  • OHSS
  • Infertility
  • GnRH antagonist
  • PCOS
  • OHSS
  • COH
  • IVF
  • Infertility
  • Polycystic Ovary Syndrome
  • Ovarian Hyperstimulation Syndrome

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