Clinical study to compare the safety and effectiveness of Actavis rhFSH (the medicine being developed) with GONAL-f (an approved medicine) in Stimulating Multiple Follicles (a woman's eggs or ova) in Women Participating in an Assisted Reproductive Technology Program (such as in vitro fertilisation, 'IVF')

Conditions: Stimulation of multifollicular development in women undergoingsuperovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intrafallopian transfer.
MedDRA version: 17.0Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2013-003788-67-BE

Lead Sponsor: Watson Laboratories, Inc. - A subsidiary of Actavis, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 471

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 < AMH < 4.5 ng/mL) at Screening;
IN04. Has a current diagnosis of infertility with one of the following categories: tubal factor, ovulation disorder, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1-2), male factor, other causes, unexplained cause, multiple factors (female only), and multiple factors (male and female);
IN05. Has both ovaries (by ultrasonography at Screening) and normal uterine cavity;
IN06. Has a male partner with semen analysis that is at least adequate for ICSI within 6 months before the first test or reference article injection (Surgically-removed or donor sperm, if adequate for ICSI, is allowed.);
IN07. Has LH, prolactin (PRL), thyroid stimulating hormone (TSH) results within the reference range for the clinical laboratory or considered not clinically significant by the Investigator at Screening;
IN08. Has current general health status that is congruent with the site’s conventional requirements for ART eligibility;
IN09. Is willing and able to comply with the requirements of the protocol;
IN10. Is willing and able to provide written informed consent and authorisation to disclose after being fully informed of the risks of participating in the study.
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 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.