A Prospective, Multicentric, Randomized, Comparative, Open Label, Parallel Group Phase IV Study To Evaluate The Efficacy, Safety And Cost Effectiveness Of Minimal Stimulation Protocol Compared To Standard Stimulation Protocol For In vitro Fertilization In Indian Population - comparison between different procedure in invitro fertilization

Indian Society of Assisted Reproduction ISAR0 个研究点目标入组 210 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.Women in the age group of 18 37 years (both inclusive) with normal ovulatory cycles
•2.Women with body mass index (BMI) between 20 and 30 kg/m2
•3.Women with primary or secondary Infertility
•4.Women with negative urine pregnancy test (UPT)
•5.Women with normal or clinically insignificant hematology and blood chemistry values.
•6.Women whose male partner does not require surgical sperm retrieval [Percutaneous epididymal sperm aspiration (PESA) or Testicular epididymal sperm aspiration (TESA)].
•7.Women with FSH, LH, Estradiol (E2),Progesterone (P4) at luteal phase, and Prolactin levels within normal range
•8.Women with both intact ovaries. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalpinx) within 6 months before randomization
•9.Male with normal sperm motility and sperm count more than 4 million/mL

•1. Women with gonadal failure or premature ovarian failure
•2. Women with FSH >10 IU/L
•3. Women with thyroid or adrenal dysfunction
•4. Women with PCOS, endometrioma (endometrial thickness >4mm) or any other active pelvic pathology
•5. Women with untreated fibroid tumors of the uterus of <4 cm in size (incompatible with pregnancy), including untreated submucous myoma and 12 weeks adenomyomas
•6. Women with >3 previously unsuccessful IVF cycles or previous IVF cycle with unsuccessful fertilization
•7. Women with history of recurrent miscarriage
•8. Women with tumors of the ovary, breast, uterus, pituitary or hypothalamus and malformations of the sexual organs (incompatible with pregnancy)
•9. Women with history of diabetes or hypertension or any other systemic disorder and on treatment for the same
•10. Women mentally incompatible for conception
•11. Women with history of hypersensitivity to any excipients of the investigational products
•12. Women who are taking concomitant medications that might interfere with study evaluations
•13. Women who have participated in another study or received any investigational product 30 days prior to enrolment or simultaneous participation in another clinical study
•14. Women who are poor responders to FSH
•15. Women with complete or partial hysterectomy

发起方

Indian Society of Assisted Reproduction ISAR