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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT01709942 (opens ClinicalTrials.gov in a new tab)Other idC05
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
80 participants (actual)
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy · Network
Design
Randomized · Single masking
Countries
1 country

Italy

Start
Nov 2012
Primary completion
Dec 2015
Completion
Dec 2015
First posted
18 Oct 2012 (estimated)
Last update posted
27 Apr 2016 (estimated)
Conditions
PCOS · OHSS · INFERTILITY

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 3

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

    NCT01709942

    Nov 2012 to Dec 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • degarelix (long acting GnRH antagonist)Drug
  • cetrorelix 0.25mgDrug

Arms2

  • Experimental

    degarelix group

    group of patients treated with long acting GnRH antagonist

  • Active comparator

    Cetrorelix 0.25mg

    patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. PREGNANCY RATE

    Time frame · 6 MONTHS

    Registry description

    number of ongoing pregnancy obtained in the group

  2. ovarian hyperstimulation syndrome rate

    Time frame · 6 MONTHS

    Registry description

    incidence of ovarian hyperstimulation syndrome in the groups

Secondary outcomes(1)

  1. implantation rate

    Time frame · 6 months

    Registry description

    number of implanted embryos divided for the number of transferred embryos

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

4 results

Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial.

García-Velasco et al. 2012Reproductive biomedicine onlinecited by 3

PMID 22197127DOI 10.1016/j.rbmo.2011.10.016PUB-22197127

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 38 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * women with PCOS * previous OHSS * Infertility Exclusion Criteria: * more than 38 years old * Body mass index pore than 30 * other systemic diseases

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