Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
Intervention1: Human Menopausal Gonadotropin - Gynogen HP (Sanzyme Pvt. Ltd, India): A starting dose of Gynogen® HP 150 IU-225 IU will be
maintained for approximately first 4-5 days. Dose adjustment
Sponsors
Sanzyme P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women undergoing COS for their first or second cycle of IVF with or without intracytoplasmic sperm injection (ICSI) with following characteristics: - Age > 21 and - Ability to provide written informed consent voluntarily for study participation, along with consent by partner or spouse - Body mass index between 18.5 and 30 kg/m2 - Basal FSH, LH, E2, P4 at luteal phase and prolactin (PRL) levels within normal range - Normal antral follicle count (AFC) (6 to 10) - Normal ovulatory cycles of 21 to 35 days inclusive 2. TVUS documenting the presence of both ovaries, without evidence of abnormality (e.g., no endometrioma) and normal adnexa (e.g., no hydrosalpinx) within 6 months prior to randomization. 3. Normal or clinically insignificant haematology and blood chemistry values. 4. Husband/male partner with normal sperm motility and sperm count.
Exclusion criteria
Exclusion criteria: 1. History of more than 2 unsuccessful induction cycles with hMG or hCG regimen or intolerability to regimens requiring discontinuation. 2. Primary or secondary ovarian failure or women known as poor responders. 3. Patient with a history of >=3 miscarriages. 4. Presence of only one ovary or ovarian abnormality or ovarian cysts >10 mm in size for >1 cycle or ovarian endometrioma. 5. Patients with polycystic ovary syndrome. 6. Hydrosalpinx that have not been surgically removed or ligated. 7. Stage III or IV endometriosis. 8. Abnormality on endometrial biopsy. 9. Patients with submucosal fibroids >=5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation 10. Tubal pathologies or history of ectopic pregnancy. 11. Prior history of OHSS. 12. Allergy, intolerance, or hypersensitivity to the study medication or its excipients. 13. Abnormal bleeding of undetermined origin. 14. Any history of malignancy or significant systemic disease (cardiovascular, gastrointestinal, pulmonary, neurological, or autoimmune), endocrine or metabolic abnormalities (pituitary,thyroid, adrenal, pancreas, hepatic or renal), or any active condition requiring treatment, which, according to the investigator, might interfere with the study. 15. Metabolic disorders such as type I or type II diabetes mellitus. 16. Tumours and malformation of sexual organs incompatible with pregnancy. 17. Hyperprolactinaemia. 18. Women with severe infections of the reproductive system such as tuberculosis, sexually transmitted diseases, etc. 19. Known positive history of human immunodeficiency virus (HIV), hepatitis B or C, or syphilis. 20. Abnormality in the partnerâ??s semen based on semen analysis. 21. Use of concomitant medication that might interfere with ovulation (e.g., neuroleptics) or study evaluations, or concomitant medications with known or suspected teratogenic agents (e.g., Food and Drug Administration Class X drugs). 22. Pregnancy, lactation, or contraindication to pregnancy. 23. Current or past (last 12 months) abuse of alcohol or drugs; women who smoke or have stopped smoking in the past 3 months. 24. Participation in a concurrent clinical trial or in another trial within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of mature oocytes retrievedTimepoint: 34 to 36 hours after human chorionic gonadotropin (hCG) administration | — |
Secondary
| Measure | Time frame |
|---|---|
| - Drug utilization in terms of total dose of hMG (IU, total number of vials, and vials per day) - Stimulation duration in terms of number of days of hMG stimulation (from stimulation onset until hCG injection) - Mean 17β-oestradiol (E2) serum concentration on the day of hCG injection - Success rate - Mean Embryo score - Fertilization rate - Implantation rate - Clinical Pregnancy rate Timepoint: At the end of the study | — |
Countries
India
Contacts
Public ContactDr Venkata Kishan P
Sanzyme P Ltd
Outcome results
None listed