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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01709942

Enrollment

Registered

2012-10-18

Start date

2012-11-30

Completion date

2015-12-31

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS, OHSS, INFERTILITY

Keywords

GnRH antagonist, PCOS, OHSS, COH, IVF

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.

Interventions

DRUGdegarelix (long acting GnRH antagonist)

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

DRUGcetrorelix 0.25mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 38 Years

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

Design outcomes

Primary

Measure	Time frame	Description
PREGNANCY RATE	6 MONTHS	number of ongoing pregnancy obtained in the group
ovarian hyperstimulation syndrome rate	6 MONTHS	incidence of ovarian hyperstimulation syndrome in the groups

Secondary

Measure	Time frame	Description
implantation rate	6 months	number of implanted embryos divided for the number of transferred embryos

Other

Measure	Time frame	Description
number of mature oocytes	6 months	number of mature oocytes obtained in each patient

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026