Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

• Conditions: Polycystic Ovarian Syndrome; Ovarian Hyperstimulation Syndrome; Invitro Fertilization
• Interventions: Drug: GnRH antagonist depot Degarelix

• Registration Number: NCT02084940
• Lead Sponsor: Bioroma

Brief Summary

PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-11
• Last Update Submitted: 2014-03-11
• Study First Posted: 2014-03-12
• Last Update Posted: 2014-03-12
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• regular menstrual cycle (26-39 days)
• primary infertility
• BMI < 30

Exclusion Criteria

• women with diabetes and other metabolic disease
• women with heart disease
• women with inflammatory or autoimmune disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GnRH antagonist depot, Degarelix	GnRH antagonist depot Degarelix	Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering

Primary Outcome Measures

Name	Time	Method
Incidence of OHSS	Time frame: until 7th gestational week
Pregnancy rate	Time Frame: until 12th gestational week

Secondary Outcome Measures

Name	Time	Method
Number of collected oocytes	Time Frame: until 12th gestational week
Estradiol level at HCG day	time frame: until 12th gestational week
Total days of stimulation	Time frame: until 12th gestational week
implantation rate	time frame: until 12th gestational week
Total dose of FSH administered	Time frame: until 12th gestational week

Trial Locations

Locations (1)

Bioroma; 🇮🇹 Rome, Italy