PERgoveriS In Stratified Treatment for Assisted Reproductive Technique

Launched by MERCK KGAA, DARMSTADT, GERMANY · Feb 15, 2011

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Be a female subject justifying an in vitro fertilization and embryo transfer (IVF/ET) treatment
• • Be between her 36th and 40th birthday (both included) at the time of the randomization visit
• • Have early follicular phase (Day 2-4) serum level of basal follicle stimulating hormone (FSH less than or equal to (=\<)12 IU/L) measured in the center's local laboratory during the screening period (that is within 2 months prior to down-regulation start)
• • A body mass index (BMI) less than (\<) 30 kilogram per square meter (kg/m\^2)
• • Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
• • Be willing and able to comply with the protocol for the duration of the trial
• • Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
• • Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
• • Other protocol specified inclusion criteria could also apply.
• 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
• • 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
• • Had previous severe ovarian Hyperstimulation Syndrome (OHSS)
• • Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
• • Any contraindication to being pregnant and/or carrying a pregnancy to term
• • History of 3 or more miscarriages (early or late miscarriages) due to any cause
• • 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
• • Known allergy or hypersensitivity to human gonadotrophin preparations
• • 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
• • Other protocol specified inclusion criteria could also apply.