Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT) MedDRA version: 7.0 Level: PT Classification code 10003539
Conditions
Interventions
Trade Name: Gonal-f®
Product Name: Gonal-f®
Product Code: Not Applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Follitropin alfa
CAS Number: 146479-72-3
Current Sponsor code
Sponsors
Serono International SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Infertile subject, between her 18th and 35th birthday (35 not included) and justifying an IVF/ET treatment. ·Male partner with semen analysis within the last 6 months considered adequate as per centre’s standard practice for IVF or intracytoplasmic sperm injection (ICSI). ·A regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length. ·An early follicular phase (Day 2-4) serum levels within the last 3 months of: · FSH = 12IU/L, and · E2 within centre’s local normal laboratory range values. ·Presence of both ovaries. ·Have at least one wash-out cycle (defined as = 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy. ·A normal uterine cavity. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Two previous ART cycles with poor or hyper response. ·Extra-uterine pregnancy within the last 3 months. ·Previous severe OHSS ·BMI > 30 kg/m2. ·History of 3 or more miscarriages (early or late miscarriages) due to any cause. ·Abnormal gynaecological bleeding of undetermined origin. ·Tumours of the hypothalamus and pituitary gland. ·Ovarian enlargement or cyst of unknown etiology. ·Ovarian, uterine or mammary cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical validation of the ART treatment guidelines, which determine the optimal dose of r?hFSH based on subject baseline characteristics/predictors of ovarian response.;Secondary Objective: Not Applicable;Primary end point(s): ·Total number of oocytes retrieved per subject. | — |
Countries
Italy, Spain, Sweden
Outcome results
None listed