Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

Bioroma

Status: Unknown

Conditions: Ovarian Hyperstimulation Syndrome; Polycystic Ovarian Syndrome; Invitro Fertilization

Treatments: Drug: GnRH antagonist depot Degarelix

Study type: Observational

Funder types: Other

Identifiers

NCT02084940

BRM002

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 23 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

GnRH antagonist depot, Degarelix

Description:

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

Treatment:

Drug: GnRH antagonist depot Degarelix