Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

Polycystic Ovarian Syndrome Clinical Trial

Official title:

The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02084940
• Other study ID #: BRM002
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2014
• Last updated: March 11, 2014
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2014
• Source: Bioroma
• Contact: Mauro Schimberni, MD
• Phone: +39063334266
• Email: bioroma[@]bioroma.net
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trial - Ministry of Health'
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 37 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Invitro Fertilization
• Ovarian Hyperstimulation Syndrome
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	Bioroma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bioroma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		Time Frame: until 12th gestational week	Yes
Primary	Incidence of OHSS		Time frame: until 7th gestational week	Yes
Secondary	Number of collected oocytes		Time Frame: until 12th gestational week	Yes
Secondary	Estradiol level at HCG day		time frame: until 12th gestational week	Yes
Secondary	Total dose of FSH administered		Time frame: until 12th gestational week	Yes
Secondary	Total days of stimulation		Time frame: until 12th gestational week	Yes
Secondary	implantation rate		time frame: until 12th gestational week	Yes