Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intrafallopian transfer. MedDRA version: 17.0 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Actavis rhFSH
Pharmaceutical Form: Solution for injection in pre-filled pen
CAS Number: 56832-30-5
Other descriptive name: FOLLITROPIN ALFA
Concentration unit: IU international unit(s)
C
Sponsors
Watson Laboratories, Inc. - A subsidiary of Actavis, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: IN01. Is in good health and 18 to 35 years of age (inclusive) with child-bearing potential at the time of screening; IN02. Has a body mass index (BMI) of 18 – 32 (inclusive); IN03. Has adequate ovarian reserve as measured by: a) the serum FSH level during the early follicular phase (menstrual cycle day 2, 3 or 4) is less than 2x the upper range of normal for the study population at Screening and b) the serum anti-Mullerian hormone (AMH) level is between 1.0 to 4.5 ng/mL (i.e., 1.0 ng/mL =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: EX01. Has participated in another study protocol or in a clinical trial with experimental medication within 30 days of Screening; EX02. Has participated in previous ART cycle before this study; EX03. Has taken clomiphene, tamoxifen, injectable GnRH agonists or antagonists, estrogen, androgens, anti-androgens, synthetic progestins, or aromatase inhibitors within 30 days of Screening; EX11. Has 12 or more follicles in either ovary, size 2 - 9 mm in diameter (calculated as the mean of the longitudinal and anteroposterior diameters) and/or an ovarian volume > 10 mL in either ovary (calculated using the formula 0.5 x length x width x thickness), as determined by transvaginal ultrasound examination at Screening Visit 3 or on Treatment Day 1 before the first test or reference article injection; EX12. Has symptoms or signs of pelvic or vaginal infection or abnormal gynecological bleeding; EX13. Has current diagnosis of or signs and symptoms that indicate adrenal dysfunction; EX14. Has a history of recurrent spontaneous abortion (3 or more); EX15. Has a history of extrauterine pregnancy in the past 6 months before Screening; EX16. Has a history of allergy or hypersensitivity to any protein based drugs, including FSH and hCG products and GnRH antagonists, or any excipient in the formulation of the test or reference articles; EX17. Is a smoker with an average > 5 cigarettes (or equivalent tobacco use of other types) a day; EX18. Is unable or unwilling to tolerate injections; EX19. Is judged by the Investigator to be unsuitable for enrollment for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate equivalence between the numbers of oocytes retrieved after treatment with Watson rhFSH or GONAL-f in ovulatory subjects participating in an ART program.;Secondary Objective: • To evaluate pregnancy rate after treatment with Watson rhFSH and GONAL-f. • To evaluate the dose requirements and duration of Watson rhFSH and GONAL-f treatment. • To evaluate the pharmacodynamic properties of Watson rhFSH and GONAL-f. • To evaluate the number of good quality oocytes and embryos after treatment with Watson rhFSH and GONAL-f. • To evaluate immunogenicity, in terms of anti-FSH antibodies, after treatment with Watson rhFSH and GONAL-f. • To evaluate the general safety of Watson rhFSH and GONAL-f. ;Primary end point(s): Number of oocytes retrieved in the first ART cycle;Timepoint(s) of evaluation of this end point: Evaluated at the end of the first ART cycle. The overall treatment duration in any ART cycle will not exceed 19 days with average expected to be around 10 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Ongoing pregnancy rate, defined as percentage of subjects with presence of at least one fetus with heart activity, at 10 weeks after embryo transfer; 2. Mean total dose of Actavis rhFSH or GONAL-f required during the ART cycle; 3. Mean number of days of Actavis rhFSH or GONAL-f stimulation during the ART cycle; 4. Percentage of subjects who require an increase or decrease of the dose of Actavis rhFSH or GONAL-f during treatment; 5. Mean number of follicles/cysts with sizes = 11 mm, = 15 mm, or = 17 mm on Treatment Day 6 (before FSH dose adjustment) and the day of hCG administration; 6. Serum concentrations of inhibin-B, E2, LH, FSH, and progesterone on Treatment Day 1 (before Actavis rhFSH or GONAL-f injection) and the day of hCG administration 7. Mean number of fertilised oocytes at 24 hours after the initiation of the IVF for subjects who are not choosing ICSI procedure; 8. Mean number of metaphase II oocytes after oocyte retrieval for subjects with ICSI procedure (metaphase II oocytes are defined as having extruded the first polar body and are in the resting phase of meiosis II); 9. Mean number of Grade 1 and Grade 2 embryos on Day 3 of embryo culture.;Timepoint(s) of evaluation of this end point: Ongoing pregnancy rate (1) will be evaluated at 10 weeks after embryo transfer. Other secondary endpoints (2, 3, 4, 8) are evaluated at the end of the first ART cycle (as for the primary endpoint). Endpoint (5) on Treatment Day 6 (before FSH dose adjustment) and the day of hCG administration, and (6) on Treatment Day 1 (before FSH injection) and the day of hCG administration. Mean number of fertilised oocytes (7) assessed at 24 hours after the initiation of the IVF for subjects who are not choosing ICSI procedure. Mean number of Grade 1 and Grade 2 embryos (9) assessed on Day 3 of embryo culture. | — |
Countries
Austria, Belgium, Spain, United Kingdom
Contacts
Public ContactProject Scientist
Watson Laboratories, Inc. - A subsidiary of Actavis, Inc
Outcome results
None listed