Recombinant Follicle-stimulating Hormone in Treatment for Infertility (REFRESH)

This is an interventional treatment trial for Female Infertility Read More

Inclusion Criteria:

• Subject has indication ART using COS.
• Subject has regular menstrual cycle of 21-35 days.

• Subject has one of the following:

  1. FSH level <10 IU/L and Estradiol levl <80 pg/mL at day 2 or 3
  2. Anti-mullerian hormone (AMH) level between 1 to 3.5 ng/mL during the menstrual cycle
• Subject has an antral follicle count (AFC) of 10- 25, follicle ≤10 mm in diameter before ovarian stimulation
• Subject has a BMI ≥18 and <30 kg/m2
• Subject has results of clinical laboratory tests within normal reference range
• Subject and her partner are willing to provide written informed consent and comply

Exclusion Criteria Details Subject has history of >2 failed ART cycles

• Subject with history of any endocrine abnormality, with documented hormone levels outside the reference range, which are clinically relevant, at screening
• Subject with a history of ovarian hyper-response (i.e., previous COS cycle with >25 follicles of ≥11 mm in diameter on USG) or OHSS
• Subject with documented polycystic ovarian syndrome (PCOS) at the time of screening
• Subject with only one ovary or ovarian abnormality (including endometrioma >10 mm; visible on USG), at screening
• Subject with documented severe endometriosis (American Society of Reproductive Medicine stage 3 or stage 4) or hydrosalpinx, at screening
• Subject with submucosal fibroids ≥5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation, at screening
• Subject with a history of extrauterine pregnancy within 3 months of screening
• Subject with history of poor response to gonadotropin treatment (retrieval of <4 oocytes) in the previous ART cycle
• Subject with history of ≥3 miscarriages, at any time prior to screening
• Subject who has tested positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C at screening
• Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r hFSH or its excipients, that will be used in the study
• Subject with contraindications to the use of gonadotropins (e.g., tumours, undiagnosed vaginal bleeding, or ovarian cysts) or gonadotropin-releasing hormone (GnRH) antagonists
• Subject with a history of epilepsy, thrombophilia, cardiovascular, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease, or any active infection, requiring treatment which at the investigator's discretion might interfere with the study
• Subject with history of malignancy
• Subject who smokes or has stopped smoking within the last 3 months prior to screening
• Subject with history of alcohol or drug abuse within 12 months prior to screening

• Subject who has received any treatment listed below within 5 half-lives prior to screening:

  1. Any agent(s) known to affect ovulation (e.g., neuroleptics);
  2. Drugs known or suspected to be teratogenic in nature.