Highly Purified Human Chorionic Gonadotropin In female Infertility

A Prospective, Multicenter, Open Label, Phase IV Clinical Trial to Test Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin For Inducing Final Follicular Maturation in Assisted Reproductive Technique(ART) - HuCoG-HP

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/02/017770

Enrollment

200

Registered

2019-02-21

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: null- Infertility

Interventions

Intervention1: Highly Purified Human Chorionic Gonadotropin: 1 vial of 10,000 IU HuCoG HP will be administered subcutaneously. Intervention2: Highly Purified Human Chorionic Gonadotropin: 1 vial of 1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject undergoing ovulation induction with injectable gonadotropins with least 1 follicle >= 18 mm in size. 2. Subject aged >20 or 3. BMI between 18 and 30 kg/m2. 4. Normogonadotrophic subjects with normal hormonal profile. 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 Hystero Contrast Salpingogram (HycoSy) or hystosalpingogram (HSG) &/or Laparoscopy within 3 years before recruitment. 7. Transvaginal ultrasound documenting the presence of both ovaries, without evidence 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 hyperprolactinemia 6. Pregnancy, lactation or contraindication to pregnancy 7. Current or past ( last 12 months) abuse of alcohol and drugs. 8. Undiagnosed vaginal bleeding . 9. Tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnacy. 10. Hypersensitivity to any trial product.

Design outcomes

Primary

Measure	Time frame
1. Serum hCG levels at 40 to 48 hours after administration of the HP-hCG injection. 2. Progestterone level more than 1.2ng/ml on 40 to 48 hrs after HP-hCG administration. 3. USG evidence of rupture of follicle.Timepoint: 40 to 48 hours	—

Secondary

Measure	Time frame
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