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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01709942
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : April 27, 2016
Information provided by (Responsible Party):
Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
PCOS OHSS INFERTILITY Drug: degarelix (long acting GnRH antagonist) Drug: cetrorelix 0.25mg Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF
Study Start Date : November 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: degarelix group
group of patients treated with long acting GnRH antagonist
Drug: degarelix (long acting GnRH antagonist)
20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration
Other Name: Firmagon
Active Comparator: Cetrorelix 0.25mg
patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol
Drug: cetrorelix 0.25mg
0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml
Other Name: cetrotide

Primary Outcome Measures :
  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 Outcome Measures :
  1. implantation rate [ Time Frame: 6 months ]
    number of implanted embryos divided for the number of transferred embryos

Other Outcome Measures:
  1. number of mature oocytes [ Time Frame: 6 months ]
    number of mature oocytes obtained in each patient

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • women with PCOS
  • previous OHSS
  • Infertility

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01709942

Rome, Italy, 00153
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Study Chair: Marco Sbracia, MD Centre for Endocrinology and Reproductive Medicine, Italy

Publications of Results:
Responsible Party: Fabio Scarpellini, Principal Investigator, Centre for Endocrinology and Reproductive Medicine, Italy Identifier: NCT01709942     History of Changes
Other Study ID Numbers: C05
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy:
GnRH antagonist

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists