women undergoing intracytoplasmatic sperm injection (ICSI) as part of assisted reproduction MedDRA version: 14.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872
Conditions
Interventions
Product Name: FSH-GEX™
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FSH
Current Sponsor code: FSH-GEX™
Other descriptive name: RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE
Conc
Sponsors
Glycotope GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the determination of the recommended standard treatment dose of FSH-GEX™ as assessed by follicle growth dynamics in women between 18 and 37 years of age undergoing intracytoplasmic sperm injection (ICSI) treatment.;Secondary Objective: Secondary objectives are as follows: 1. To compare the efficacy of the different FSH-GEX treatment arms and Gonal-f. 2. To compare the safety and tolerability of the FSH-GEX treatment arms and Gonal-f. ;Primary end point(s): The number of follicles with a diameter of = 12 mm on the day of hCG injection or the day before, after stimulation with FSH-GEX™ compared with Gonal-f®.;Timepoint(s) of evaluation of this end point: on the day of hCG injection or the day before | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • Follicular response: for each ovary the number of follicles will be classified and summarised as follows: mean diameter 8.0 – 9.9 mm, 10.0 – 11.9 mm, 12.0 – 13.9 mm, 14.0 – 15.9 mm, 16.0 – 17.9 mm, 18.0 – 19.9 mm and larger 19.9 mm • The number of retrieved cumulus-oocyte-complexes (COCs) • The number of oocytes retrieved (metaphase II) • The number of 2PN oocytes one day after follicle puncture • The rate of biochemical pregnancy and the clinical pregnancy (defined as gestational sac with heartbeat) per randomised patient/puncture/embryo transfer • Implantation rate (number of foetal sacs on sonography divided by number of embryos transferred per embryo transfer) • Number of doses and total dose of follicle-stimulating hormone (FSH) • Pharmacokinetic data for exposure-response relationship exploration • Pharmacodynamic effect of FSH-GEX™ on E2-estradiol (E2), inhibin B • Post-study observation: ongoing pregnancy rate (>10 weeks of gestation) and live birth rate ;Timepoint(s) of evaluation of this end point: see protocol | — |
Countries
Germany, Hungary
Contacts
Public ContactReception
Glycotope GmbH
Outcome results
None listed