Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Infertile women who are candidates for ART will be prospectively screened for enrollment at
      24 clinical trial sites in the United States and Argentina. Enrolled subjects will start
      treatment using oral contraceptives (OCP) and will then receive a Gonadotropin releasing
      hormone (GnRH)-agonist (leuprolide acetate) for pituitary desensitization. Once
      down-regulation is achieved, the subjects will be randomized in a 1:1:1:1 ratio to begin
      ovarian stimulation with one of 3 doses of AS900672-Enriched or with follitropin alfa
      (Gonal-f®) daily injections. Subjects will be recruited to the four study arms in parallel.
      Beginning on S1, the subjects will receive either a single injection of AS900672-Enriched or
      start daily injections of follitropin alfa. The subjects' response to treatment will be
      monitored by ovarian ultrasound and E2 levels. On S6, subjects randomized to
      AS900672-Enriched may begin receiving supplemental follitropin alfa 150 IU, according to the
      each subject's ovarian response, and subjects randomized to follitropin alfa 150 IU daily
      injections will continue treatment at the same dose. Recombinant human chorionic gonadotropin
      (r-hCG, Ovidrel®) will be administered to subjects meeting response criteria and who are not
      at risk for ovarian hyperstimulation syndrome (OHSS). Oocyte retrieval will occur within
      34-38 hours after r-hCG administration and subjects will begin luteal phase support using
      vaginal progesterone (Crinone® 8 percent or Prochieve® 8 percent) the following day.
      Fertilization will be done by conventional IVF or ICSI. Embryo transfer will occur in
      accordance with the specific requirements of each subject and the clinical trial site's
      standard practice, with the exception that a maximum of two embryos at the cleavage or
      blastocyst stage may be transferred. Subjects who undergo embryo transfer will be assessed
      for pregnancy and a follow-up visit will be performed 15-20 days post r-hCG administration.
      Subjects with a positive pregnancy test will undergo a confirmatory ultrasound evaluation at
      Day 35 - 42 post r-hCG. Additionally, all subjects recruited at certain trial centers will
      participate in a pharmacokinetic (PK) sub-study.
    

Intervention name(s): 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 type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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).
Other intervention name(s): Hyperglycosylated r-hFSH; Hyperglycosylated r-hFSH; Hyperglycosylated r-hFSH; Gonal-f®; Follicle stimulating hormone (FSH); Ovidrel®; Choriogonadotropin alfa
Intervention MeSH terms: Chorionic Gonadotropin; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Assisted reproductive technology, follicle stimulating hormone