Recombinant follicle-stimulating hormone in treatment for infertility

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

Subject has indication ART using COS.

-Subject has regular menstrual cycle of 21-35 days.

-Subject has one of the following:

a. FSH level <10 IU/L and Estradiol levl <80 pg/mL at day 2 or 3

b. AMH level between 1 to 3.5 ng/mL during the menstrual cycle

-Subject has an 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

-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 GnRH antagonists

- Subject with a history of epilepsy, thrombophilia, cardiovascular, gastro-intestinal, 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:

a.Any agent(s) known to affect ovulation (e.g., neuroleptics);

b.Drugs known or suspected to be teratogenic in nature.

- Subject who has received an investigational product or has used an invasive investigational medical device within 30 days before the planned first dose of the study drug; or is currently enrolled in an investigational study