Long Acting GnRH Antagonist in PCOS Women Undergoing IVF
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
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 12, 2014
March 1, 2014
9 months
March 10, 2014
March 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pregnancy rate
Time Frame: until 12th gestational week
Incidence of OHSS
Time frame: until 7th gestational week
Secondary Outcomes (5)
Number of collected oocytes
Time Frame: until 12th gestational week
Estradiol level at HCG day
time frame: until 12th gestational week
Total dose of FSH administered
Time frame: until 12th gestational week
Total days of stimulation
Time frame: until 12th gestational week
implantation rate
time frame: until 12th gestational week
Study Arms (1)
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
Interventions
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
Eligibility Criteria
Women with PCOS with a previous IVF attempt cancelled due to the risk of OHSS
You may qualify if:
- regular menstrual cycle (26-39 days)
- primary infertility
- BMI \< 30
You may not qualify if:
- women with diabetes and other metabolic disease
- women with heart disease
- women with inflammatory or autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioromalead
Study Sites (1)
Bioroma
Rome, Italy, 00197, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2014
First Posted
March 12, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
March 12, 2014
Record last verified: 2014-03