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Completed

NCT Number: NCT01709942

Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)

In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.

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Key information

Conditions

PCOS Genital Diseases Infertility OHSS Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cerm-Hungaria

Rome, 00153, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women with PCOS
  • previous OHSS
  • Infertility

Exclusion criteria

  • more than 38 years old
  • Body mass index pore than 30
  • other systemic diseases

Treatment and study plan

degarelix (long acting GnRH antagonist)

Drug

20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration

Other names: Firmagon

cetrorelix 0.25mg

Drug

0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml

Other names: cetrotide

Primary outcomes

  1. PREGNANCY RATE

    Time frame: 6 MONTHS

    number of ongoing pregnancy obtained in the group

  2. ovarian hyperstimulation syndrome rate

    Time frame: 6 MONTHS

    incidence of ovarian hyperstimulation syndrome in the groups

Secondary outcomes

  1. implantation rate

    Time frame: 6 months

    number of implanted embryos divided for the number of transferred embryos

Other outcomes

  1. number of mature oocytes

    Time frame: 6 months

    number of mature oocytes obtained in each patient

Sponsors and collaborators

Lead sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Network

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2012
Registry last updated
Apr 27, 2016

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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