Study to evaluate and compare the efficacy and safety of various doses of FSH-GEX with an accepted comparator in women undergoing intracytoplasmatic sperm injection (ICSI) as part of assisted reproductio

• Conditions: women undergoing intracytoplasmatic sperm injection (ICSI) as part of assisted reproduction; MedDRA version: 16.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-003006-27-DE
• Lead Sponsor: Glycotope GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-09
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1.Female patient for whom ICSI treatment is justified at the investigator`s discretion and who is willing to undergo ICSI treatment using ejaculated sperm.
2.Aged 18 – 37 years at Screening.
3.Serum follicle-stimulating hormone (FSH) concentration = 12 IU/l measured between Day 1 and Day 5 of a spontaneous menstrual cycle. Measured within six months before randomisation.
4.Anti-mullerian hormone (AMH): 1 - 4 ng/ml. Measured within six months before randomisation.
5.Antral follicle count (sum of both ovaries): = 7 and = 20.
6.Body mass index (BMI) 18.5-30 kg/m² and body weight = 45 kg and = 90 kg.
7.Presence of both ovaries.
8.Regular spontaneous cycles between 21 and 35 days in length (intercycle variations not more than ± 5 days).
9.Normal uterine cavity as assessed by transvaginal sonography at Screening. No fibroids as assessed by the investigator that would require treatment to facilitate pregnancy.
10.Willing and able to comply with the protocol.
11.Willing and able to provide written informed consent
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 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients who had more than two unsuccessful previous assisted reproduction technology (ART) cycles (IVF or ICSI) before inclusion into the study, where unsuccessful is defined as no embryo transfer or no biochemical or clinical pregnancy was achieved.
2.Previous poor responders: < 3 oocytes retrieved in previous treatment cycles.
3.Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome.
4.Patients with a history of or current polycystic ovarian morphology (PCO) syndrome) according to the Rotterdam consensus criteria
5.Patients with a history of or current endometriosis III or IV according to the American Society for Reproductive Medicine (ASRM) criteria (ASRM, 1996).
6.Presence of ovarian cyst at Screening.
7.Any contraindication to becoming pregnant.
8.History of = 3 clinical or preclinical (absence of gestational sac) miscarriages.
9.An abnormal cervical smear (Papanicolaou [PAP] score = 3, obtained within one year prior to randomisation).
10.Any history of malignant cancer other than in situ breast or skin cancer requiring local excision.
11.Any endocrine abnormalities requiring treatment (latent hypothyroidism treated by thyroxin is allowed).
12.Any clinically significant systematic disease, including history of hormonal abnormalities (e.g. Cushing’s syndrome or androgen producing tumours).
13.Any known infection with human immunodeficiency virus (HIV), hepatitis B or C.
14.History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting.
15.Family history of genetic risk factors concerning pregnancy or birth.
16.Use of concomitant medication, which in the opinion of the investigator might interfere with ICSI preparation procedures.
17.Active smoking (no smoking at all allowed) up to four weeks before enrolment in the trial.
18.Any active substance abuse of drugs, medications or alcohol within the last five years.
19.Patients in an institution by official or court order.
20.Patients who are unable or unwilling to provide informed consent.
21.Any participation in another clinical trial within the last 60 days before randomisation.
22.Previous FSH-GEX™ administration.
23.Known hypersensitivity to any component of the investigational and non investigational products used in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified