Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle MedDRA version: 20.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872 MedDRA version: 20.0 Level: LLT Classification code 10016403 Term: Female infertility of tubal origin System Organ Class: 100000004872 MedDRA version: 20.0 Level: LLT Classification code 10025511 Term: Male infertili
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed Consent Documents signed prior to screening evaluations. 2. In good physical and mental health. 3. The subjects must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation. 4. 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. 5. Infertility for at least one year before randomisation for subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. AMH >35 pmol/L at screening. 2. Strong preference of the subject for either treatment protocol. 3. Known endometriosis stage III-IV (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996). 4. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy). 5. Known abnormal karyotype of subject or of her partner / sperm donor, as applicable, depending on source of sperm used for insemination in this trial. 6. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes). 7. Known inherited or acquired thrombophilia disease. 8. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. 9. Known porphyria. 10. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease. 11. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins. 12. Known moderate or severe impairment of renal or hepatic function. 13. Currently breast-feeding. 14. Undiagnosed vaginal bleeding. 15. Known abnormal cervical cytology of clinical significance observed within 3 years prior to randomisation (unless the clinical significance has been resolved). 16. 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. 17. Pregnancy (negative pregnancy test must be documented at screening) or contraindication to pregnancy. 18. Known current active pelvic inflammatory disease. 19. Use of fertility modifiers during the last menstrual cycle before randomisation, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations. 20. Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle before randomisation. 21. Known history of chemotherapy (except for gestational conditions) or radiotherapy. 22. Current or past (1 year prior to randomisation) abuse of alcohol or drugs and/or current (last month) intake of more than 14 units of alcohol per week. 23. Current or past (3 months prior to randomisation) smoking habit of more than 10 cigarettes per day. 24. Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial. 25. Previous participation in the trial 26. Use of any non-registered investigational drugs during the last 3 months prior to randomisation. See also Withdrawal Criteria in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of individualised FE 999049 treatment on ovarian response in a long GnRH agonist protocol versus a GnRH antagonist protocol;Secondary Objective: • To evaluate the effect of individualised FE 999049 treatment on other pharmacodynamic parameters in a long GnRH agonist protocol versus a GnRH antagonist protocol • To evaluate the effect of individualised FE 999049 treatment on pregnancy rates in a long GnRH agonist protocol versus a GnRH antagonist protocol • To evaluate the safety of individualised FE 999049 treatment in a long GnRH agonist protocol versus a GnRH antagonist protocol;Primary end point(s): Number of oocytes retrieved ;Timepoint(s) of evaluation of this end point: Oocyte retrieval will take place 36h (±2h) after triggering of final follicular maturation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects with cycle cancellation due to poor ovarian response or excessive ovarian response • Proportion of subjects with blastocyst transfer cancellation after oocyte retrieval due to (risk of) ovarian hyperstimulation syndrome (OHSS) • Number and size of follicles on stimulation day 6 and end-of-stimulation • Proportion of subjects with <4, 4-7, 8-14, 15-19 and =20 oocytes retrieved • Number of metaphase II oocytes (only applicable for those inseminated using ICSI), fertilisation rate as well as number and quality of embryos on day 3 and blastocysts on day 5 after oocyte retrieval • Circulating concentrations of FSH, luteinising hormone (LH), estradiol, progesterone and inhibin B on stimulation day 6, end-of-stimulation and at oocyte retrieval • Total gonadotropin dose and number of stimulation days • Positive ßhCG rate (positive serum ßhCG test 13-15 days after transfer) • Implantation rate (number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred) • Clinical pregnancy rate (at least one gestational sac 5-6 weeks after transfer) • Vital pregnancy rate (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer) • Ongoing pregnancy rate (at least one intrauterine viable fetus 10-11 weeks after transfer • Ongoing implantation rate (number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred) • Proportion of subjects with early OHSS (including OHSS of moderate/severe grade) • Proportion of subjects with late OHSS (including OHSS of moderate/severe grade) • Frequency and intensity of adverse events • Technical malfunctions of the prefilled injection pen;Timepoint(s) of evaluation of this end point: Timepoint is included in the relevant endpoint | — |
Countries
Austria, Denmark, Israel, Italy, Netherlands, Norway, Switzerland
Contacts
Public ContactGlobal Clinical R&D
Ferring Pharmaceuticals A/S
Outcome results
None listed