Health Condition 1: N97- Female infertility Health Condition 2: null- Infertility
Conditions
Interventions
Intervention1: Recombinant Human Chorionic Gonadotropin: Single Dose of 250 microgram (6000 IU) Injection Administered Subcutaneous
Control Intervention1: Ovitrelle: Single dose of 250 microgram (60
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects aged 20 to 37 years (both inclusive) 2. BMI between 18 and 30 kg/m2 3. Less than 3 previous completed cycles 4. Anovulatory infertility, grade I or II endometriosis , PCOS or unexplained factor 5. Normogonadotropic subjects with normal Day 2 hormonal profile ( FSH (2.5 to 10.2 mIU/ml), LH (1.9 to 12.5mIU/ml), E2 (18.9 to 246.7pg/ml) TSH (0.35 to 5.5µIU/ml) and Prolactin (2.8 to 29.2ng/ml) 6. Criteria for hCG administration fulfilled (at least 1 follicle and not more than 5 follicles with diameter of > 18mm with acceptable serum E2 concentration not more than 1800 pg/ml) 7. Hysterosalpingography or laparoscopy, within 3 years before randomization, documenting a uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) and at least one patent tube. 8. Semen parameters compatible with IUI using husband/donor sperm and semen analysis documenting >10 million/ml sperm count.
Exclusion criteria
Exclusion criteria: 1. Female subjects aged less than 20 yrs and more than 37 years 2. Premature ovarian failure 3. Subjects requiring more than 300 IU of HMG/FSH as starting dose in previous treatment cycles or a known poor responder 4. Subjects with hypogondatropic hypogonadism 5. Uncontrolled thyroid or adrenal dysfunction 6. Previous history of severe Ovarian Hyper Stimulation Syndrome (OHSS) 7. Ovarian cysts > 10 mm or enlargement not due to polycystic ovary syndrome 8. Bilateral tubal block 9. Abnormal gynaecological bleeding of unknown origin 10. More than 3 previous failed IUIs 11. Subjects affected by pathologies associated with any contraindication of being pregnant 12. Neoplasias 13. Use of concomitant medication that might interfere with study evaluations 14. Hypersensitivity to any trial product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serum hCG levels will be noted 36 ± 4 hours after administration of the hCG injection 2. USG evidence of rupture of follicle. Timepoint: 36 ± 4 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy rateTimepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactMs Naju Turakhia
Bharat Serums & Vaccines Ltd
Outcome results
None listed