Recombinant Human Chorionic Gonadotropin in Infertility

Phase 3

Completed

• Conditions: Health Condition 1: N97- Female infertilityHealth Condition 2: null- Infertility

• Registration Number: CTRI/2014/09/005010
• Lead Sponsor: Bharat Serums and Vaccines Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-05-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 217

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified