Health Condition 1: O80- Encounter for full-term uncomplicated delivery Health Condition 2: E894- Postprocedural ovarian failure
Conditions
Interventions
Intervention1: FE 999049: subjects will be randomised in a 1:1 ratio to treatment with either FE 999049 or GONAL-F, and stimulation will be initiated.
for a maximum of 20 days
Control Intervention1: G
Sponsors
Ferring Pharmaceuticals AS
Ferring Pharmaceuticals AS
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the criteria listed below to be eligible for participation in the trial. 1. Informed Consent Forms signed prior to screening evaluations. 2. In good physical and mental health as judged by the investigator. 3. Indian (i.e., possessing an Indian identification card and having native Indian parents) pre-menopausal females between the ages of 21 and 40 years. The subjects must be at least 21 years (including the 21st 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 (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996) 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 6. The trial cycle will be the subject’s first controlled ovarian stimulation cycle for IVF/ICSI. 7. Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory. 8. Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomisation. 9. Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval. 10. Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to randomisation). 11. Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within 1 year prior to randomisation. 12. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening. 13. Willing to accept transfer of 1-2 embryos.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the criteria listed below will not be eligible for participation in the trial. 1. Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996). 2. One or more follicles =10 mm (including cysts) observed on the transvaginal ultrasound prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation). 3. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy). 4. Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial. 5. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes). 6. Known inherited or acquired thrombophilia disease. 7. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. 8. Known porphyria. 9. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease. 10. Known presence of anti-FSH antibodies (based on the information available in the subject’s medical records). 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. Any abnormal finding of clinical chemistry, haematology or vital signs at screening which is clinically significant as judged by the investigator. 14. Currently breast-feeding. 15. Undiagnosed vaginal bleeding. 16. Known abnormal cervical cytology of clinical significance observed within 3 years prior to randomisation (unless the clinical significance has been resolved). 17. 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. 18. Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomisation) or contraindication to pregnancy. 19. Known current active pelvic inflammatory disease. 20. 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. 21. Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle before randomisation. 22. Known history of chemotherapy (except for gestational conditions) or radiotherapy. 23. Current or past (1 year prior to randomisation) abuse of alcohol or drugs. 24. Current (last month) intake of more than 14 units of alcohol per week. 25. Current or past (3 months prior to randomisation) smoking habit of more than 10 cigarettes per day. 26. Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial. 27. Previous participation in the trial. 28. Use of any non-registered investigational drugs during the last 3 months prior to randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rateTimepoint: 10-11 weeks after embryo transfer | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in circulating levels of clinical chemistry and proportion of subjects with markedly abnormal changesTimepoint: At screening, at end-of-stimulation (up to 20 stimulation days), and at end-of-trial (up to approximately 5.5 months) ;Changes in circulating levels of clinical haematology parameters and proportion of subjects with markedly abnormal changes Timepoint: At screening, at end-of-stimulation (up to 20 stimulation days), and at end-of-trial (up to approximately 5.5 months) ;Circulating concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, inhibin A and inhibin B Timepoint: At end-of-stimulation (up to 20 stimulation days);Circulating concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, inhibin A and inhibin B Timepoint: On stimulation day 6;Clinical pregnancy rateTimepoint: 5-6 weeks after embryo transfer;Fertilisation rateTimepoint: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation);Frequency and intensity of adverse eventsTimepoint: From signing of the informed consent up to end-of-trial (approximately 5.5 months)];Frequency and intensity of immune-related adverse eventsTimepoint: From signing of the informed consent up to end-of-trial (approximately 5.5 months);Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed by the subject during the stimulation period Timepoint: At end-of-stimulation (up to 20 stimulation days);Implantation rateTimepoint: 5-6 weeks after embryo transfer;Number and quality of embryos on day 3 after oocyte retrievalTimepoint: On Day 3 after oocyte retrieval (up to 25 days after start of stimulation);Number of follicles at end-of-stimulationTimepoint: At end-of-stimulation (up to 20 stimulation days);Number of follicles on stimulation Day 6Timepoint: On stimulation Day 6;Number of oocytes retrievedTimepoint: On day of oocyte retrieval (up | — |
Countries
India
Contacts
Public ContactShiraz Kandawalla
Ferring Pharmaceuticals Pvt. Ltd
Outcome results
None listed