Highly Purified Follicle Stimulating Hormone In Female Infertility

A Prospective, Multicenter, open, Phase IV Clinical Trial to test efficacy and safety of Highly Purified Follicle-Stimulating Hormone in subjects Undergoing assisted reproductive Technique (ART)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004303

Enrollment

200

Registered

2014-01-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N97- Female infertility Health Condition 2: null- Infertility

Interventions

Intervention1: Highly Purified Follicle-Stimulating Hormone: Subject will receive 1 to 4 vials per day of 75 IU Foliculin HP for about 6 - 12 days. Control Intervention1: Not Applicable: Not Applicabl

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject undergoing ovulation induction with injectable HP FSH 2. Subject age > 20 or 3. BMI between 18 to 30 kg/m2 4. Normogonadotrophic subjects with normal ( 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

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.

Design outcomes

Primary

Measure	Time frame
1. Total number of follicles â?¥ 16mm in diameter. 2. Total dose of foliculin HP received. 3.Total days of stimulation with foliculin HP required to achieve follicle size â?¥ 16 mm in diameter.Timepoint: 6 to 12 days	—

Secondary

Measure	Time frame
1. Chemical pregnancy rate 2. Clinical pregnancy rateTimepoint: 4 weeks	—

Countries

India

Contacts

Public ContactKishma Vinod

Bharat Serums and Vaccines Ltd.

naju.turakhia@bharatserums.com9987267718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026