Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

• Sponsor: Bioroma (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02084940
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 11.1
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome; Ovarian Hyperstimulation Syndrome; Invitro Fertilization	Drug: GnRH antagonist depot Degarelix

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Mar 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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	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

Outcome Measures

Primary Outcome Measures

1. Pregnancy rate [Time Frame: until 12th gestational week]

2. Incidence of OHSS [Time frame: until 7th gestational week]

Secondary Outcome Measures

1. Number of collected oocytes [Time Frame: until 12th gestational week]

2. Estradiol level at HCG day [time frame: until 12th gestational week]

3. Total dose of FSH administered [Time frame: until 12th gestational week]

4. Total days of stimulation [Time frame: until 12th gestational week]

5. implantation rate [time frame: until 12th gestational week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 37 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bioroma	Rome		Italy	00197

Sponsors and Collaborators

• Bioroma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bioroma
• ClinicalTrials.gov Identifier: NCT02084940
• Other Study ID Numbers: BRM002
• First Posted: Mar 12, 2014
• Last Update Posted: Mar 12, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Bioroma: PCOS; OHSS; GnRH antagonist; IVF; COH
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome; Syndrome

Study Results

No Results Posted as of Mar 12, 2014