Health Condition 1: null- Female infertility
Conditions
Interventions
Intervention1: Menotropin (Human Menopausal Gonadotropin 75 IU, 150 IU): The initial starting dose is 150-225 IU/day.The dose is adjusted according to the ovarian response. Treatment is continued unti
Sponsors
LG Life Sciences India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Regular menstrual cycles of 24 to 35 days of duration, Normal basal FSH and LH during the early follicular phase, antral size follicles more than 5, Normal functional ovaries and uterus, Infertility due to any of the following factors: tubal factor, endometriosis (stage 1 or 2), male factor or unexplained factor, Willing to give voluntary written consent
Exclusion criteria
Exclusion criteria: 1. Uterine myoma (fibroids) 2. Subjects with primary ovarian failure, uncontrollable hyperthyroidism or secondary adrenal insufficiency 3. Body Mass Index 30 kg/m2 4. Subjects with previous history of ovarian hyperstimulation syndrome (OHSS) in the previous IVF cycles 5. More than 3 previously consecutive unsuccessful IVF cycles 6. Any significant systemic disease, endocrine or metabolic abnormalities 7. Tumors of the ovary, breast, uterus, hypothalamus or pituitary gland 8. Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD) 9. Intracranial bleeding 10. An organic intracranial lesion such as pituitary tumor 11. HIV or syphilis positive subjects 12. History of alcohol or drug addiction 13. Subjects smoking more than 5 cigarettes per day 14. History of hypersensitivity to hMG or other pharmaceutical excipients of this drug 15. Positive serum pregnancy test 16. Undiagnosed vaginal bleeding 17. Subjects unable to understand the objectives, methods, etc. of this clinical study and are unable to comply with the study procedures 18. Participation in any other clinical trial within 3 months of registering in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrievedTimepoint: At the end of one in vitro fertilization cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Total administration dosage and duration of menotropin stimulation Serum estradiol level on the day of hCG Number of follicles 16mm on the day of hCG Number of follicles more than or equal to 14mm on the day of hCG Number of oocytes fertilized and fertilization rate Number of embryos transferred Embryo Implantation rate Clinical pregnancy rate Incidence rate of ovarian hyperstimulation syndrome Adverse events Laboratory test results Timepoint: At the end of one IVF cycle | — |
Countries
India
Contacts
Public ContactDr Mita Nandy
LG Life Sciences India Pvt Ltd
Outcome results
None listed