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

Conditions: Ovarian stimulation in women undergoing assisted reproductive technology
MedDRA version: 9.1Level: LLTClassification code 10021930Term: Infertility NOS

Registration Number: EUCTR2008-001259-22-NL

Lead Sponsor: Merck Serono International S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 200

Inclusion Criteria

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
Number of subjects for this age range:
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

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,
10.Tumours of the hypothalamus and pituitary gland,
11.Ovarian enlargement or cyst of unknown aetiology,
12.Ovarian, uterine or mammary cancer,
13.A clinically significant systemic disease,
14.Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner,
15.Abnormal gynaecological bleeding of undetermined origin,
16.Known allergy or hypersensitivity to human gonadotrophin preparations,
17.Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit,
18.Entered previously into this trial or simultaneous participation in another clinical trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The overall objective of this trial is to:<br>Compare the ovarian response in ART subjects administered GONAL-f according to the CONSORT calculator versus given a standard GONAL-f dose of 150 IU per day.<br>;Secondary Objective: ;Primary end point(s): Endpoints:<br>The primary efficacy endpoint will be measured by the total number of oocytes retrieved per subject following GONAL-f stimulation and human chorionic gonadotrophin (r hCG (Ovidrel/Ovitrelle) injection in both treatment arms.

Secondary Outcome Measures