Health Condition 1: N970- Female infertility associated withanovulation Health Condition 2: null- Infertility
Conditions
Interventions
Intervention1: Foligrafâ?¢: Group I â?? Subjects, who have not taken any exogenous follicle stimulating hormone preparation prior to their enrollment into the study and who receive the first cycle of
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects, who have not taken any exogeneous follicle stimulating hormone preparation prior to their enrollment into the study and who receive the first cycle of controlled ovarian stimulation with foligraf or Subjects who receive foligraf for second consecutive cycle or Subjects who receive foligraf for third consecutive cycle 2. Premenopausal female subjects aged 20 to 40 years both inclusive. 3. Normal uterine cavity and atleast one normal tube confirmed on 3D US and HycoSy or HSG &/or Laproscopy within 1 year before recruitment. 4. Signed informed consent form before screening
Exclusion criteria
Exclusion criteria: 1.Subjects more than 40 or less than 20 years of age. 2.Subjects who have received any injectable gonadotropin. 3.Infertility attributable to severe endometriosis (Grade III or IV). 4.Pelvic pathology that would compromise ART success. 5.Any chronic systemic disease including uncorrected thyroid disorders and hyper-prolactinemia. 6.Pregnancy, lactation or contraindication to pregnancy. 7.History of current or past (last 12 months) abuse of alcohol or drugs. 8.History of tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy. 9.History of hypersensitivity to any gonadotropins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of subjects testing positive for Anti- r-hFSH Antibody (ADA) 2.Incidence and absolute frequency of AEs reported in the trial which were related to r-hFSH. Timepoint: Day 30 & 90 post IUI/ET | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.No. of follicles â?¥16 mm 2.Total dose and duration of Foligrafâ?¢ 3.Chemical pregnancy rate 4.Clinical pregnancy rate 5.Cycle cancellation rate Timepoint: 4 Weeks | — |
Countries
India
Contacts
Public ContactKishma Vinod
Bharat Serums and Vaccines Ltd.
Outcome results
None listed