Health Condition 1: N979- Female infertility, unspecified
Conditions
Interventions
Intervention1: rFSH (Foligraf): 150IU
Control Intervention1: rFSH (Foligraf): 225IU
Sponsors
Indian Society of Assisted Reproduction ISAR
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean percentage of grade 1 oocytes retrieved 2. Mean percentage of fertilization rateTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean total dose in IU required to achieve follicle size &#8805;18 mm in diameter (from the day of r-hFSH administration to the Day of Human Chorionic Gonadotropin [HCG] administration) 2. Percentage of Clinical Pregnancy rate 3. Number of mature and immature oocytes 4. Ratio of mature and immature oocytes 5. Number of grade I embryos 6. Percentage of Chemical Pregnancy rate 7. Mean days of stimulation with r-hFSH required to achieve follicle size &#8805;18 mm in diameter 8. Risk of OHSS 9. Incidence & Absolute Frequency of AE?s reported in the trial which were related to study drugs administered in Group A & Group B Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr. Sadhana Desai
Outcome results
None listed