Highly Purified Follicle Stimulating Hormone In Female Infertility

Phase 4

Completed

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

• Registration Number: CTRI/2014/01/004303
• Lead Sponsor: Bharat Serums Vaccines Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-09-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 203

Inclusion Criteria

1. Subject undergoing ovulation induction with injectable HP FSH

2. Subject age > 20 or <=40 years (Both Inclusive)

3. BMI between 18 to 30 kg/m2

4. Normogonadotrophic subjects with normal ( < 10 mIU/ml)FSH

5. Male partner with semen parameters compatible with ART using ejaculated sperm.

6. Normal uterine cavity and at least one normal tube confirmed on 3D US and HycoSy or HSG &/or Laproscopy within 3 yars before recruitment.

7. Transvaginal ultrasound documenting the presence of two ovaries, without of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalphinx)within 6 months before recruitment.

8. Signed Informed consent form before screening.

Exclusion Criteria

1. Subject 20 or 40 years of age.

2. Infertility attributable to severe endometriosis (grade III or IV)

3. Subjects whose male partner needs surgical sperm retrieval.

4. Pelvic pathology that would compromise ART success.

5. Any chronic systemic disease including uncorrected hyperthyroid, hypothyroid and hyperprolactinemia

6. Pregnancy, lactation or contraindication to pregnancy.

7. Current or past (last 12 months)abuse of alcohol or drugs.

8. Undiagnosed vaginal bleeding.

9. tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy.

10. Hypersensitivity of any trial product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified