Health Condition 1: N97- Female infertility
Conditions
Interventions
Intervention1: Foligraf
900 IU (66.0 µg) / 1.5mL Solution for Injection in Prefilled Pen: Follicle Stimulating Hormone (Human Recombinant) manufactured by Bharat Serums and Vaccines Ltd
fixed dose of
Sponsors
Bharat Serums and Vaccines Limited
Eligibility
Inclusion criteria
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 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 - 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
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved.Timepoint: Oocyte pick up | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rateTimepoint: 4 weeks after embryo transfer;Cycle cancellation rateTimepoint: at Stimulation phase, oocyte pick up, embryo transfer;Endometrial thickness (mm)Timepoint: day 6 and day of hCG injection;Estradiol, Luteinizing, Progesterone, and inhibin b levelsTimepoint: day 6;Exploratory 2. Evaluation of immunogenicity of r-hFSHTimepoint: Baseline, 4 weeks and 12 weeks;Exploratory 1. Ease of use of PenTimepoint: during and end of stimulation;Number and size distribution of follicles (11mm, 11 14 mm, 15 mm, 16 mm, 17 mm and =18 mm)Timepoint: Day 6 and day of hCG administration;Number of days of r-hFSH stimulationTimepoint: at end of stimulation;Number of good quality embryosTimepoint: At Embryo transfer;Ongoing pregnancy rateTimepoint: 11±1 weeks after embryo transfer;Proportion of matured oocytesTimepoint: oocyte pickup;Proportion of subjects requiring change in doseTimepoint: post Day 6 till end of stimulation;safety - 1 Incidence of TEAETimepoint: Throughout the study- during stimulation till end of study.;Safety 2. Incidence of OHSSTimepoint: during the stimulation till end of study;Total dose of r-hFSH (in IU) required for ovarian stimulation;Timepoint: at end of stimulation | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Ramesh Jagannathan
Bharat Serums and Vaccines Limited
Outcome results
None listed