Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
Condition: Infertility
MeSH terms: Infertility
Intervention: AS900672-Enriched 50 microgram (mcg); AS900672-Enriched 100 mcg; AS900672-Enriched 150 mcg; Follitropin alfa 150 international unit (IU); Recombinant human chorionic gonadotropin (r-hCG)
Intervention description: Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.; Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.; Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.; Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 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, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels will approximately 150 picogram per milliliter [pg/mL] per mature follicle).
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: 520.0
Sex: Female
Minimum age: 18 Years
Maximum age: 36 Years
Healthy volunteers: No
Keywords: Assisted reproductive technology, follicle stimulating hormone

Summary:

      This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind,
      active-comparator, dose-finding study to evaluate a new investigational long-acting follicle
      stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive
      technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection
      [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently
      marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to
      the number of fertilized oocytes.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Infertility and desire to conceive, justifying ART treatment

          -  Age between 18 and 36 years, inclusive, at time of informed consent

          -  Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive

          -  Regular spontaneous menstrual cycles of 21 to 35 days

          -  Presence of both ovaries

          -  Transvaginal ultrasound within 6 weeks and hysterosalpingogram, hysterosonogram or
             hysteroscopy within 2 years prior to beginning OCP treatment, showing no clinically
             significant uterine abnormality, which, in the Investigator's opinion, could impair
             embryo implantation or pregnancy continuation

          -  Normal early follicular phase (Day 2-4) serum FSH level, according to the local
             laboratory

          -  Normal serum thyroid stimulating hormone (TSH) level, according to the local
             laboratory

          -  Papanicolaou (PAP) smear test without clinically significant abnormalities within the
             last 6 months prior to beginning oral contraceptive therapy,

          -  Negative pregnancy test prior to beginning GnRH-agonist therapy

          -  Male partner with semen analysis which is at least adequate for ICSI within last 6
             months prior to beginning GnRH agonist therapy, according to local laboratory

          -  Willing and able to comply with the protocol

          -  Voluntary provision of written informed consent, prior to any study-related procedure
             that was 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, and

          -  Willingness to provide follow-up information on babies born as part of this study

          -  For subjects recruited at PK sub-study centers, voluntary provision of written
             informed consent to participate in the PK sub-study

        Exclusion Criteria:

          -  Subject who require a starting dose of FSH greater than (>) 150 international unit per
             day (IU/day), in the opinion of the Investigator

          -  Screening ultrasound demonstrating more than 12 follicles less than (<) 11 mm mean
             diameter in either ovary

          -  Two or more previous ART cycles (consecutive or not) with poor response to
             gonadotrophin, defined as less than or equal to (=<)3 oocytes retrieved

          -  Three or more previous consecutive ART cycles without a biochemical or clinical
             pregnancy

          -  Previous failure of fertilization with ICSI

          -  A previous ART attempt in which there were no adequate or motile sperm before or after
             the processing of ejaculated sperm

          -  Previous severe OHSS

          -  History or presence of tumors of the hypothalamus or pituitary gland

          -  History or presence of ovarian, uterine or mammary cancer

          -  History or presence of ovarian enlargement or cyst of unknown etiology, or presence of
             ovarian cyst >25 mm on the day of randomization

          -  Presence of endometriosis Grade III - IV

          -  Presence of uni- or bilateral hydrosalpinx

          -  Abnormal gynecological bleeding of undetermined origin

          -  Contraindication to being pregnant and/or carrying a pregnancy to term

          -  History of >= 3 clinical or preclinical (absence of gestational sac) miscarriages due
             to any cause

          -  Extra-uterine pregnancy within the 3 months prior to randomization

          -  Clinically significant concurrent disease that would have compromised subject safety
             or interfered with the study assessments

          -  Known infection with human immunodeficiency virus (HIV), hepatitis B or C virus in the
             female or male partner

          -  Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds
             that are structurally similar to any of the other medications administered during the
             study

          -  Any medical condition, which in the judgment of the Investigator may have interfere
             with the absorption, distribution, metabolism or excretion of r-hFSH

          -  Any active substance abuse or history of drug, medication or alcohol abuse within 5
             years before screening

          -  ART cycle and/or ovarian stimulation within 30 days prior to informed consent

          -  Entered previously into this study or simultaneous participation in another clinical
             trial

          -  Subject is a smoker consuming more than 5 cigarettes per day

          -  In the opinion of the Investigator, either assisted hatching or pre-implantation
             genetic diagnosis is indicated for the subject

          -  Planning to undergo experimental procedures such as blastomere biopsy, or

          -  Any known autoimmune disease