A phase IIIB, multicentre, multinational, randomized, open-label trial to compare the efficacy and safety of ovarian stimulation with GONAL-f day 1 to day 5 followed by Pergoveris starting day 6 to Pergoveris starting day 1 in women between 36 and 40 years of age undergoing assisted reproductive technique (ART)- (PERSIST) - PERSIST study (PERgoveriS In Stratified Treatment) for ART

Conditions: FERTILITY DISORDERS
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2010-023534-23-IT

Lead Sponsor: MERCK SERONO SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 208

Inclusion Criteria

? Female subject justifying an IVF/ET treatment, ? Between her 36th and 40th birthday (both Pergoveris phase IIIB 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) < 30 kg/m2, ? Regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length, ? Presence of both ovaries, ? Normal uterine cavity, which in the Investigator’s opinion is compatible with pregnancy, ? Negative cervical PAP test within the last 6 months prior to randomisation, ? At least one wash-out cycle (defined as = 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy, ? Willing and able to comply with the protocol for the duration of the trial, ? Having 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prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care, ? Having a male partner with semen analysis within the past 6 months prior to randomisation considered adequate to proceed with regular insemination or ICSI according to the centre’s standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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): The primary efficacy endpoint will be measured by the total number of oocytes retrieved per subject following ovarian stimulation.;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 Outcome Measures