Fertility disorders MedDRA version: 12.1 Level: LLT Classification code 10016398 Term: Female infertility MedDRA version: 12.1 Level: LLT Classification code 10016399 Term: Female infertility (primary)
Conditions
Interventions
Trade Name: Pergoveris
Product Name: Pergoveris®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Lutropin alfa
CAS Number: 152923-57-4
Other descriptive name: L
Sponsors
Merck Serono S.A. - Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female subject justifying an IVF/ET treatment, - Between her 36th and 40th birthday (both included) at the time of the randomisation visit, - Early follicular phase (day 2-4) serum level of basal FSH =12 IU/L measured in the centre’s local laboratory during the screening period (i.e. within 2 months prior to down regulation start), - Body mass index (BMI) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Had = 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as = 6 mature follicles and/or = 4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as = 25 oocytes retrieved, - Had = 3 previous ART cycles, - Any medical condition, which in the judgment 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, - Previous severe OHSS, - Patients with primary ovarian failure, - Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS, - Presence of endometriosis requiring treatment, - Uterine myoma requiring treatment, - Any contraindication to being pregnant and/or carrying a pregnancy to term, - Extra-uterine pregnancy within the last 3 months prior to screening, - History of 3 or more miscarriages (early or late miscarriages) due to any cause, - Tumours of the hypothalamus and pituitary gland, - History or presence of ovarian enlargement or cyst of unknown aetiology, - Ovarian, uterine or mammary cancer, - A clinically significant systemic disease, - Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner, - Abnormal gynaecological bleeding of undetermined origin, - Known allergy or hypersensitivity to human gonadotrophin preparations, - Smoking = 10 cigarettes per day, - Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit, - Entered previously into this trial or simultaneous participation in another clinical trial, - Pregnancy and lactation period, - Participation in another clinical trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this trial is to generate data on the ovarian stimulation profile obtained when Pergoveris® is started either on stimulation day 1 or stimulation day 6 in ART patients between 36 and 40 years of age (both inclusive).;Secondary Objective: To further investigate the efficacy and safety profile of Pergoveris® in ART patients between 36 and 40 years of age. ;Primary end point(s): Total number of oocytes retrieved per subject following ovarian stimulation. | — |
Countries
Denmark, Finland, Germany, Greece, Italy, Netherlands, United Kingdom
Outcome results
None listed