A clinical trial to see the effects, safety and patient compliance of two drugs Newmon-Râ?¢ pre filled syringe and Gonal-FÂ® pen in infertile women undergoing IVF treatment

A multi-centre, open label, randomized, controlled parallel design phase IV study to compare and evaluate the clinical efficacy, safety and patient compliance of Newmon-Râ?¢ (rhFSH) Pre-filled Syringe versus Gonal-FÂ® Pen in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003749

Enrollment

120

Registered

2013-06-13

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: null- Female infertility

Interventions

Intervention1: Newmon-Râ?¢ Pre-filled Syringe: The initial starting dose is 150-225 IU/day commencing on mense day 2. The dose is adjusted according to the ovarian response. Treatment is continued unt

Eligibility

Inclusion criteria

Inclusion criteria: 1.Infertile women between 20-39 years of age 2.Basal FSH less than 10 IU/L 3.Regular menstrual cycles of 24to 35 days of duration 4.Antral size follicles more than 5 5.Normal functional ovaries and uterus 6.Willing to give voluntary written consent

Exclusion criteria

Exclusion criteria: 1.Uterine myoma (fibroids) 2.Subjects with primary ovarian failure, uncontrollable hyperthyroidism or secondary adrenal insufficiency 3.Body Mass Index more than 30 kg/m2 4.Subjects with previous history of ovarian hyperstimulation syndrome in the previous IVF cycles 5.More than 3 previously consecutive unsuccessful IVF cycles 6.Any significant systemic disease, endocrine or metabolic abnormalities 7.Tumors of the ovary, breast, uterus, hypothalamus or pituitary gland 8.Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD) 9.HIV or syphilis positive subjects 10.History of alcohol or drug addiction 11.Subjects smoking more than 5 cigarettes per day 12.History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug 13.Positive serum pregnancy test 14.Undiagnosed vaginal bleeding 15.Subjects unable to understand the objectives, methods, etc. of this clinical study and are unable to comply with the study procedures 16.Participation in any other clinical trial within 3 months of registering in this study

Design outcomes

Primary

Measure	Time frame
Total number of oocytes retrievedTimepoint: At the end of one IVF cycle	—

Secondary

Measure	Time frame
Total administration dosage of rhFSH Duration of rhFSH stimulation E2 concentration on the day of hCG administration Number of follicles more than 16mm in diameter on the day of hCG administration Number of follicles more than or equal to 14 mm on the day of hCG Number of oocytes fertilized and fertilization rate Number of embryos transferred Embryo implantation rate Clinical pregnancy rate Incidence rate of OHSS Compliance score Patient assessment for useTimepoint: At the end of one IVF cycle	—

Measure

Time frame

Total administration dosage of rhFSH Duration of rhFSH stimulation E2 concentration on the day of hCG administration Number of follicles more than 16mm in diameter on the day of hCG administration Number of follicles more than or equal to 14 mm on the day of hCG Number of oocytes fertilized and fertilization rate Number of embryos transferred Embryo implantation rate Clinical pregnancy rate Incidence rate of OHSS Compliance score Patient assessment for useTimepoint: At the end of one IVF cycle

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Countries

India

Contacts

Public ContactDr Mita Nandy

LG Life Sciences India Pvt Ltd

deepali.mittal@lglsi.com0124-4830000

Outcome results

None listed

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