hormonal deficiency reduced natural fecundity (infertility)
Conditions
Interventions
* GONAL-f® (Liquid Pen
300 IU of per day) stimulation day 1-5 followed by
Pergoveris® (vial/powder, 300 IU per day) from stimulation day 6 and until
required r-hCG level is met. The dose can be adjusted from stimulation d
Sponsors
Merck
Eligibility
Age
18 Years to 99 Years
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)
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 ³ 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 |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To further investigate the efficacy and safety profile of Pergoveris® in ART patients between 36 and 40 years of age. | — |
Countries
Netherlands
Outcome results
None listed