A phase IV prospective, multicentre, randomized, open-label trial to assess the efficacy and safety of GONAL f® at a dose based on subject baseline characteristics determined according to the CONSORT calculator compared with a standard dose of GONAL f® 150 IU per day for ovarian stimulation in women undergoing assisted reproductive technology (ART) - CONSORT RCT in ART

Merck Serono International S.A.0 sites0 target enrollmentMarch 12, 2009

Overview

No summary available.

Registry

who.int

Start Date

March 12, 2009

End Date

April 23, 2010

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Merck Serono International S.A.

•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 \<12 IU/L measured in the centre’s own laboratory and taken within 2 months prior to down\-regulation start.
•BMI \<30 kg/m2,
•regular menstrual cycles between 21 and 35 days,
•have both ovaries present,
•male partner with semen analysis within the last 6 months prior to the randomisation visit considered adequate as per centre’s standard practice for IVF or intracytoplasmic sperm injection (ICSI). If these criteria are not met, the subject can only be entered if donor sperm will be used,
•receiving long GnRH agonist protocol – Day 21\-22 of preceding cycle until day of hCG.
•Are the trial subjects under 18? no

•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,