AS900672-Enriched in Ovulation Induction
AS900672-Enriched in Ovulation Induction
This is a Phase 2, interventional, multi-center, randomized, assessor-blind,
 active-comparator, dose-finding study to evaluate a new investigational long-acting follicle
 stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI).
 This study will compare 4 doses of the investigational drug versus a currently marketed drug
 follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.
The study was terminated after Merck Serono had taken the decision not to pursue the
 development of AS900672-enriched in ovulation induction (OI). This decision was not related
 to any safety or efficacy concerns over the use of AS900672-Enriched in OI.
Inclusion Criteria:

 -  Oligo-anovulation defined by a menstrual period of 35 days to 6 months

 -  Spontaneous menses or a positive response to progestin within the prior 6 months or
 response to clomiphene citrate evidenced by ovulation within the prior 6 months

 -  Age between 18 and 36 years, inclusive, at time of informed consent signature

 -  Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive

 -  No clinically significant abnormalities in serum thyroid stimulating hormone (TSH),
 dehydroepiandrosterone (DHEA-S), prolactin, and FSH levels in the early follicular
 phase. Subjects low TSH level who receive replacement therapy could be enrolled at the
 discretion of the investigator if local laboratory results (thyroxine [T4])
 demonstrated satisfactory thyroid function. Subjects receiving stable dose of dopamine
 agonists could be enrolled at the discretion of the investigator if local laboratory
 results demonstrated adequate control of prolactin levels

 -  No clinically significant abnormalities in fasting glucose and fasting insulin levels

 -  Normal uterine cavity and presence of at least one ovary with ipsilateral patent
 fallopian tube, as determined by means of hysterosalpingography, laparoscopy,
 hysteroscopy or combination of these procedures within the prior 3 years

 -  Papanicolaou (PAP) smear test without clinically significant abnormalities within 6
 months prior to the first screening procedure. If PAP smear is not done, it must be
 performed as part of screening procedures

 -  Negative pregnancy test prior to randomization

 -  Male partner with semen analysis demonstrating adequacy for insemination via
 intercourse and/or intrauterine insemination (IUI) within 6 months prior to the first
 screening procedure. If semen analysis is not done, it must be performed as part of
 screening procedures

 -  Willing and able to comply with all protocol procedures, including pregnancy and
 neonatal follow-up

 -  Voluntary provision of written informed consent, prior to any trial-related procedure
 that is not part of normal medical care, with the understanding that the subject could
 withdraw consent at any time without prejudice to her future medical care, including
 willingness to provide follow-up information on babies born as part of this trial

 Exclusion Criteria:

 -  History of >=2 consecutive gonadotrophin stimulation cycles that did not lead to
 ovulation

 -  History of clomiphene citrate stimulation cycles of which none lead to ovulation

 -  Prior excessive response to gonadotrophin stimulation, defined as the development of
 at least 4 mature follicles (greater than [>]17 mm) or cancellation of the OI cycle
 due to excessive follicular response after treatment with FSH at a dose of less than
 75 IU/day

 -  Previous severe ovarian hyperstimulation syndrome (OHSS)

 -  Administration of any gonadotrophin, clomiphene citrate, gonadotrophin releasing
 hormone (GnRH) analogue, tamoxifen or aromatase inhibitors within the prior 30 days

 -  Laparoscopic ovarian drilling and/or ovarian cauterization within the prior 6 months

 -  Any contraindication to pregnancy and/or to carrying pregnancy to term

 -  A clinical pregnancy that ended in a miscarriage within the prior 3 months

 -  History of >=3 consecutive miscarriages, due to any cause

 -  Abnormal gynecological bleeding of undetermined origin

 -  Clinically significant abnormal findings of the uterine cavity evident on a
 transvaginal pelvic ultrasound performed during screening

 -  Presence of endometriosis, Grade III - IV or requiring treatment

 -  Ovarian cyst with a mean diameter of >25 mm on the day of randomization

 -  History or suspicion of ovarian, uterine or mammary cancer

 -  Adrenal congenital hyperplasia, partial or complete enzymatic block

 -  Use of metformin or other insulin sensitizing agents related to infertility within the
 prior 2 months

 -  Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds
 that are structurally similar to any of the other medications administered during the
 trial

 -  Any contra-indication to gonadotrophin therapy

 -  Known or suspected infection with human immunodeficiency virus (HIV), Hepatitis B or C
 in the trial subject or her male partner

 -  Any active substance abuse or history of drug, medication or alcohol abuse within 5
 years

 -  Smoker consuming more than 5 cigarettes per day

 -  Serum testosterone (central laboratory) that is suggestive of ovarian tumor

 -  Previously randomized in this trial or participation in another investigational drug
 clinical trial within the prior 3 months

 -  Any medical condition, which in the judgment of the investigator may interfere with
 the absorption, distribution, metabolism or excretion of r-hFSH

 -  Clinically significant concurrent disease (including diabetes mellitus and autoimmune
 diseases) that would compromise subject safety or interfere with the study assessments
 or clinically significant abnormal laboratory finding