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

Primary Purpose

PCOS, OHSS, INFERTILITY

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
degarelix (long acting GnRH antagonist)
cetrorelix 0.25mg
Sponsored by
Centre for Endocrinology and Reproductive Medicine, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring GnRH antagonist, PCOS, OHSS, COH, IVF

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with PCOS
  • previous OHSS
  • Infertility

Exclusion Criteria:

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

Sites / Locations

  • Cerm-Hungaria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

degarelix group

Cetrorelix 0.25mg

Arm Description

group of patients treated with long acting GnRH antagonist

patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol

Outcomes

Primary Outcome Measures

PREGNANCY RATE
number of ongoing pregnancy obtained in the group
ovarian hyperstimulation syndrome rate
incidence of ovarian hyperstimulation syndrome in the groups

Secondary Outcome Measures

implantation rate
number of implanted embryos divided for the number of transferred embryos

Full Information

First Posted
October 17, 2012
Last Updated
April 25, 2016
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01709942
Brief Title
Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)
Official Title
Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, OHSS, INFERTILITY
Keywords
GnRH antagonist, PCOS, OHSS, COH, IVF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
degarelix group
Arm Type
Experimental
Arm Description
group of patients treated with long acting GnRH antagonist
Arm Title
Cetrorelix 0.25mg
Arm Type
Active Comparator
Arm Description
patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol
Intervention Type
Drug
Intervention Name(s)
degarelix (long acting GnRH antagonist)
Other Intervention Name(s)
Firmagon
Intervention Description
20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration
Intervention Type
Drug
Intervention Name(s)
cetrorelix 0.25mg
Other Intervention Name(s)
cetrotide
Intervention Description
0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml
Primary Outcome Measure Information:
Title
PREGNANCY RATE
Description
number of ongoing pregnancy obtained in the group
Time Frame
6 MONTHS
Title
ovarian hyperstimulation syndrome rate
Description
incidence of ovarian hyperstimulation syndrome in the groups
Time Frame
6 MONTHS
Secondary Outcome Measure Information:
Title
implantation rate
Description
number of implanted embryos divided for the number of transferred embryos
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
number of mature oocytes
Description
number of mature oocytes obtained in each patient
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with PCOS previous OHSS Infertility Exclusion Criteria: more than 38 years old Body mass index pore than 30 other systemic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Sbracia, MD
Organizational Affiliation
Centre for Endocrinology and Reproductive Medicine, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Cerm-Hungaria
City
Rome
ZIP/Postal Code
00153
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22197127
Citation
Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.
Results Reference
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Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)

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