Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
Intervention1: Follicle Stimulating Hormone - ENDOGEN HP (Sanzyme P Ltd): FSH will be given s.c. or i.m. (dose in the range of 150-225 IU)
starting from day 2 to day 5 of the current menstrual cycle (
Sponsors
Sanzyme P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with all of the following criteria were considered for inclusion: 1. Women with unexplained infertility undergoing COS for their first or second cycle of IVF with or without intracytoplasmic sperm injection (ICSI), irrespective of the outcome of first IVF cycle with following characteristics: - Age >21 and - Ability to provide written informed consent voluntarily for study participation, along with consent by partner or spouse. - A BMI between 18.5 and 30 kg/m2. - Basal FSH, luteinizing hormone (LH), E2, progesterone (P4) and prolactin (PRL) levels within normal range in cycle 1 Day 1. - Normal ovarian response: antral follicular count (AFC) >=10 and anti-Müllerian hormone (AMH) level >=1.0 ng/mL but - Normal ovulatory cycles of 21 to 35 ±2 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 or male partner, or donor with normal sperm motility and sperm count or with non-severe male factor infertility (defined as a semen concentrate 5 to 15�106 /mL or sperm with progressive motility (type a+b) 10% to 32%), including mild-to-moderate oligospermia, with or without asthenospermia.
Exclusion criteria
Exclusion criteria: 1. History of more than 2 unsuccessful induction cycles with FSH/ human menopausal gonadotropin (hMG) or hCG regimen or intolerability to these regimens requiring discontinuation. 2. History of >=3 clinically confirmed miscarriages. 3. Persistent ovarian cysts more than 10 mm in size for >1 cycle or ovarian endometrioma. 4. Polycystic ovarian syndrome (PCOS). 5. Submucosal or intramural fibroids >=5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation. 6. Tumours and malformation of sexual organs incompatible with pregnancy. 7. Hydrosalpinx that has not been surgically removed or ligated. 8. Stage III or IV endometriosis (per revised American Society for Reproductive Medicine classification, 2012). 9. History of ectopic pregnancy. 10. Prior history of OHSS. 11. Hypersensitivity to study medication or its excipients. 12. Abnormal bleeding of undetermined origin. 13. Any significant systemic disease or endocrine disorders (pituitary, thyroid, adrenal, pancreas, liver, or kidney) or any active condition requiring treatment, which, according to the Investigator, might interfere with the study. 14. Metabolic disorders such as uncontrolled type I or type II diabetes mellitus. 15. Untreated hyperprolactinaemia. 16. Severe infections of the reproductive system such as tuberculosis and sexually transmitted diseases. 17. Receiving donor oocytes 18. Known history of human immunodeficiency virus (HIV), hepatitis B or C, or syphilis infection. 19. Use of the concomitant medication that might interfere with study evaluation 20. Pregnancy, lactation, or contraindication to pregnancy 21. Current or past (last 12 months) abuse of alcohol or drugs 22. 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 hCG administration | — |
Secondary
| Measure | Time frame |
|---|---|
| - Total dose of FSH - Number of days of FSH stimulation - Mean E2 serum concentration - Number of mature follicles - Follicle oocyte index (FOI) - Follicular output rate (FORT) - Number of mature oocytes - Number of inseminated oocytes - Mean embryo score - Total number of embryos transferred, frozen, or discarded - Fertilization rate - Implantation rate - Clinical pregnancy rate - IVF cancellation rate - Ongoing pregnancy rate - Number of adverse eventsTimepoint: At the end of the study | — |
Countries
India
Contacts
Public ContactDr Venkata Kishan Pokuri
Sanzyme P Ltd
Outcome results
None listed