A Prospective, Multicenter, open, Phase IV Clinical Trial to test efficacy and safety of Highly Purified Follicle-Stimulating Hormone in subjects Undergoing assisted reproductive Technique (ART)

Bharat Serums Vaccines Ltd0 个研究点目标入组 203 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subject undergoing ovulation induction with injectable HP FSH
•2. Subject age > 20 or <=40 years (Both Inclusive)
•3. BMI between 18 to 30 kg/m2
•4. Normogonadotrophic subjects with normal ( < 10 mIU/ml)FSH
•5. Male partner with semen parameters compatible with ART using ejaculated sperm.
•6. Normal uterine cavity and at least one normal tube confirmed on 3D US and HycoSy or HSG &/or Laproscopy within 3 yars before recruitment.
•7. Transvaginal ultrasound documenting the presence of two ovaries, without of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalphinx)within 6 months before recruitment.
•8. Signed Informed consent form before screening.

•1. Subject 20 or 40 years of age.
•2. Infertility attributable to severe endometriosis (grade III or IV)
•3. Subjects whose male partner needs surgical sperm retrieval.
•4. Pelvic pathology that would compromise ART success.
•5. Any chronic systemic disease including uncorrected hyperthyroid, hypothyroid and hyperprolactinemia
•6. Pregnancy, lactation or contraindication to pregnancy.
•7. Current or past (last 12 months)abuse of alcohol or drugs.
•8. Undiagnosed vaginal bleeding.
•9. tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy.
•10. Hypersensitivity of any trial product.

发起方

Bharat Serums Vaccines Ltd