NCT01709942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

3.1 years

First QC Date

October 17, 2012

Last Update Submit

April 25, 2016

Conditions

PCOSOHSSINFERTILITY

Keywords

GnRH antagonistPCOSOHSSCOHIVF

Outcome Measures

Primary Outcomes (2)

  • PREGNANCY RATE

    number of ongoing pregnancy obtained in the group

    6 MONTHS

  • ovarian hyperstimulation syndrome rate

    incidence of ovarian hyperstimulation syndrome in the groups

    6 MONTHS

Secondary Outcomes (1)

  • implantation rate

    6 months

Other Outcomes (1)

  • number of mature oocytes

    6 months

Study Arms (2)

degarelix group

EXPERIMENTAL

group of patients treated with long acting GnRH antagonist

Drug: degarelix (long acting GnRH antagonist)

Cetrorelix 0.25mg

ACTIVE COMPARATOR

patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol

Drug: cetrorelix 0.25mg

Interventions

degarelix (long acting GnRH antagonist)DRUG

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

Also known as: Firmagon
degarelix group
cetrorelix 0.25mgDRUG

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

Also known as: cetrotide
Cetrorelix 0.25mg

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PCOS
  • previous OHSS
  • Infertility

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerm-Hungaria

Rome, 00153, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22197127RESULT

MeSH Terms

Conditions

Infertility

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamidecetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Marco Sbracia, MD

    Centre for Endocrinology and Reproductive Medicine, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 18, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

IT(1)