Infertility MedDRA version: 20.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872
Conditions
Interventions
Product Code: FE 999302
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Choriogonadotropin beta
Current Sponsor code: FE 999302
Other descriptive name: HUMAN CHORIONIC GONADOTROPIN
Co
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject informed consent form signed prior to any trial-related activities. 2. Parental informed consent form signed prior to start of stimulation in the trial. 3. In good physical and mental health as judged by the investigator. 4. Pre-menopausal women between the ages of 18 and 42 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent. 5. Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor. 6. Infertility for at least 1 year before screening for subjects =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV 2. Considered unsuitable for controlled ovarian stimulation with a starting dose of 150 or 225 IU/day highly purified human menopausal gonadotropin (HP-hMG), as judged by the investigator. 3. Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day or higher. Poor response is defined as <4 oocytes retrieved, or cycle cancellation prior to oocyte retrieval due to inadequate follicular development. 4. Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/hMG dose of <225 IU, defined as =25 oocytes retrieved or cycle cancellation prior to oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS). 5. Severe OHSS in a previous controlled ovarian stimulation cycle. 6. One or more follicles =10 mm (including cysts) observed on the transvaginal ultrasound prior to start of ovarian stimulation on stimulation day 1 (puncture of cysts is allowed prior to start of stimulation). 7. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy and before week 24 of pregnancy, excluding ectopic pregnancy). 8. Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial. In case partner sperm will be used and the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y-chromosome microdeletion, must be documented. 9. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes). 10. Known inherited or acquired thrombophilia disease. 11. Known active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. 12. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease. 13. Known presence of anti-hCG antibodies (based on the information available in the subject’s medical records; i.e. not based on the anti-hCG antibody analyses conducted in the trial). 14. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins. 15. Known impairment of renal or hepatic function. 16. Any abnormal finding of clinical chemistry and haematology at screening or vital signs at randomisation, which is judged clinically relevant by the investigator and/or requires intervention. 17. Currently breast-feeding. 18. Undiagnosed vaginal bleeding. 19. Known abnormal cervical cytology of clinical significance observed within 3 years prior to start of stimulation in the trial (unless the clinical significance has been resolved). 20. Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device. 21. Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to start of stimulation) or contraindication to pregnancy. 22. Known current active pelvic inflammatory disease. 23. Use of fertility modifiers during the last menstrual cycle before start of stimulation in the trial, including dehydroepiandrosterone (DHEA) or cycle progra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of 150, 200, and 250 µg of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on oocyte maturity when administered for triggering of final follicular maturation in women undergoing controlled ovarian stimulation;Secondary Objective: 1. To compare the effect of 150, 200, and 250 µg of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on fertilisation, blastocyst quality, endocrine profile during the luteal phase, and pregnancy, when administered for triggering of final follicular maturation in women undergoing controlled ovarian stimulation 2. To compare the safety of 150, 200, and 250 µg of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL when administered for triggering of final follicular maturation in women undergoing controlled ovarian stimulation 3. To investigate the impact of body weight on FE 999302 exposure and assess the population pharmacokinetics of FE 999302 when administered for triggering of final follicular maturation in women undergoing controlled ovarian stimulation ;Primary end point(s): Number of metaphase II (MII) oocytes;Timepoint(s) of evaluation of this end point: 36 hours (+/- 2h) after triggering of final follicular maturation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Secondary Efficacy Endpoints 1.1 Number of oocytes retrieved 1.2 Number of fertilised (2 pronuclei) oocytes 1.3 Number and quality of embryos 1.4 Number and quality of blastocysts 1.5 Serum hormone concentrations of progesterone, 17-OH-progesterone, estradiol, follicle-stimulating hormone (FSH), and luteinising hormone (LH) 1.6 Positive ßhCG (positive serum ßhCG test) 1.7 Clinical pregnancy (at least one gestational sac) 1.8 Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat) 1.9 Ongoing pregnancy (at least one intrauterine viable fetus) 2. Secondary Pharmacokinetics Endpoint 2.1 Serum hCG concentrations 3. Secondary Safety Endpoints 3.1 Ovarian hyperstimulation syndrome (OHSS), overall and by grade and severity 3.2 Injection site reactions (redness, pain, itching, swelling, and bruising) assessed by the subject following administration of investigational medicinal product (IMP) 3.3 Treatment-induced anti-hCG antibodies, overall as well as with neutralising capacity 3.4 Multi-fetal gestation, biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention), and vanishing twins 4. Exploratory Endpoint 4.1 Biomarkers of oocyte maturation and/or OHSS in follicular fluid and granulosa cells;Timepoint(s) of evaluation of this end point: 1.3 on day 3 after oocyte retrieval 1.4 on day 5 after oocyte retrieval 1.5 at end-of-stimulation, the day after triggering, at oocyte retrieval, on day 5 after oocyte retrieval (transfer), on day 7-9 after oocyte retrieval (mid-luteal phase), and 13-15 days after transfer 1.6 13-15 days after transfer 1.7 5-6 weeks after transfer 1.8 5-6 weeks after transfer 1.9 10-11 weeks after transfer 2.1 at end-of-stimulation, the day after triggering, at oocyte retrieval, on day 5 after oocyte retrieval (transfer), and on day 7-9 after oocyte retrieval (mid-luteal phase) 3. Secondary Safety Endpoints ongoing throughout the trial | — |
Countries
Czech Republic, Denmark, Spain
Contacts
Public ContactGlobal Clinical Development
Ferring Pharmaceuticals A/S
Outcome results
None listed