AS900672-Enriched in Ovulation Induction
Condition: Ovulation Induction
Intervention: AS900672-Enriched 10 microgram (mcg); AS900672-Enriched 20 mcg; AS900672-Enriched 30 mcg; AS900672-Enriched 40 mcg; Follitropin alfa 75 international unit (IU); Recombinant human chorionic gonadotropin (r-hCG)
Intervention description: Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.; Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.; Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.; Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.; Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.; Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm).
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Maximum age: 36 Years
Healthy volunteers: No
Keywords: Infertility; Oligo-anovulation; GONAL-f®; AS900672-Enriched; hyperglycosylated recombinant human follicle stimulating hormone (r-hFSH)

Summary:

      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.
    

Eligibility criteria:

        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