Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity (LH/M2-Oocyte)
Infertility
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF-ET, ICSI, Gonadotrophins, rFSH, rLH, Cetrorelix, Leuprolide acetate
Eligibility Criteria
Inclusion Criteria:
- Women aged 18-40 years
- Primary or secondary infertility
- Desire to achieve pregnancy
- Basal FSH <12 mIU/ML
- Moderate to good ovarian reserve (antimullerian hormone (AMH) >1ng/ml, and/ or antral follicle count (AFC)>8 between both ovaries)
- Informed written consent from both partners
- BMI <35 kg/mtr.sq.
- No genetic abnormality
Exclusion Criteria:
- Hormonal preparation taken within 3 month prior to recruitment
- Women with previous poor response to gonadotrophins
- History of previous 3 or more miscarriages
- Women with uncorrected tubal/uterine pathology
- Women opting for assisted procedures like embryo hatching etc.
Sites / Locations
- Sat Kaival Hospital Pvt. Ltd.Recruiting
- Disha Fertility & Surgical HospitalRecruiting
- Southern Cross Fertility CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Study subjects desiring pregnancy
Control subjects desiring pregnancy
Study subjects to be treated with rFSH, rLH throughout controlled ovarian hyperstimulation (COH) in appropriate dosages,considering age, body mass index (BMI), ovarian reserve, etc. and GnRH antagonist, cetrorelix in 0.25 mg/d when needed till the desired follicular maturity and the minimum required number of follicles are achieved. INTRVENTIONS - Monitoring at regular intervals by transvaginal ultrasound and hormonal studies.Once pregnancy established by beta-human chorionic gonadotropin (hCG) and ultrasound will be supported by intervention of adequate luteal support by estrogen (E) + progesterone (P) for 12 weeks of gestation.
Control subjects selected in randomized way,desiring pregnancy will be treated with gonadotrophins, rFSH and rLH in appropriate dosages considering age, BMI, ovarian reserve, etc. after standard downregulation with GnRH agonist, Leuprolide acetate, 1 mg/d under established 'Long Luteal Suppression Protocol' from the previous cycle. INTERVENTIONS - Monitoring of response to treatment by hormonal study and sonography evaluation at regular intervals during COH till adequate number of mature follicles of minimum 18 mm mean diameter is achieved, to be followed by hCG trigger and ovum pick-up (OPU) and embryo transfer (ET). Chemical pregnancy by beta-hCG would be confirmed 14 days post-ET. Clinical pregnancy would be confirmed by sonography 6 weeks after ET (visibility of yolk sac and fetal heart-beat). Pregnancy support by E+P for 12 weeks would be provided.