Invitro Fertilization, Ovarian Hyperstimulation Syndrome, Polycystic Ovarian Syndrome
Conditions
Keywords
PCOS, OHSS, GnRH antagonist, IVF, COH
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.
Interventions
DRUGGnRH 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
Sponsors
Bioroma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
23 Years to 37 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate | Time Frame: until 12th gestational week |
| Incidence of OHSS | Time frame: until 7th gestational week |
Secondary
| Measure | Time frame |
|---|---|
| Total dose of FSH administered | Time frame: until 12th gestational week |
| Number of collected oocytes | Time Frame: until 12th gestational week |
| implantation rate | time frame: until 12th gestational week |
| Total days of stimulation | Time frame: until 12th gestational week |
| Estradiol level at HCG day | time frame: until 12th gestational week |
Countries
Italy
Contacts
Primary ContactMauro Schimberni, MD
Outcome results
None listed