Ovarian stimulation in women undergoing assisted reproductive technology MedDRA version: 9.1 Level: LLT Classification code 10021930 Term: Infertility NOS
Conditions
Interventions
Trade Name: Gonal-f
Product Name: Gonal-f
Pharmaceutical Form: Solution for injection
INN or Proposed INN: follitropin alfa
Concentration unit: IU/ml international unit(s)/millilitre
Concentration typ
Sponsors
Merck Serono International S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The target population includes subjects with the following attributes: •female subject justifying an IVF/ET treatment, •between the age of 18 and 35 years (35 not included) at the time of the randomisation visit, •an early follicular phase (Day 2-4) serum level of basal FSH =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible for inclusion in this trial the subjects must not meet any of the following criteria: 1.Had =2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as <5 mature follicles and/or < 3 oocytes collected) or had =2 previous ART cycles with a hyper response (defined as =25 oocytes retrieved), 2.Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical responsible, 3.Had previous severe OHSS, 4.Polycystic ovary syndrome to reduce the risk of the occurrence of OHSS, 5.Presence of endometriosis requiring treatment, 6.Uterine myoma requiring treatment, 7.Any contraindication to being pregnant and/or carrying a pregnancy to term, 8.Extra-uterine pregnancy within the last 3 months prior to screening, 9.History of 3 or more miscarriages (early or late miscarriages) due to any cause, 10.Tumours of the hypothalamus and pituitary gland, 11.Ovarian enlargement or cyst of unknown aetiology, 12.Ovarian, uterine or mammary cancer, 13.A clinically significant systemic disease, 14.Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner, 15.Abnormal gynaecological bleeding of undetermined origin, 16.Known allergy or hypersensitivity to human gonadotrophin preparations, 17.Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit, 18.Entered previously into this trial or simultaneous participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this trial is to: Compare the ovarian response in ART subjects administered GONAL-f according to the CONSORT calculator versus given a standard GONAL-f dose of 150 IU per day. ;Secondary Objective: ;Primary end point(s): Endpoints: The primary efficacy endpoint will be measured by the total number of oocytes retrieved per subject following GONAL-f stimulation and human chorionic gonadotrophin (r hCG (Ovidrel/Ovitrelle) injection in both treatment arms. | — |
Countries
Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed