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Clinical Trial on Efficacy and Safety of Foropin (Follitropin Alfa biosimilar) by Humer Novin Daroo in comparison with Gonal-f by Merck Serono in assisted reproductive technology (ART)

Phase III, Randomized, Parallel Groups, Active-control, Double-blind Non-inferiority Clinical Trial on Efficacy and Safety of Foropin (Follitropin Alfa biosimilar) by Humer Novin Daroo in comparison with Gonal-f by Merck Serono in assisted reproductive technology (ART)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20101012004920N13
Enrollment
303
Registered
2025-01-30
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Female infertility. Female infertility, unspecified

Interventions

Intervention 1: Intervention: Foropin group: 150 - 300 units per day of Foropin by Humer Novin Daroo (based on previous menstrual assessment and ovarian sonography) will be administered subcutaneously

Sponsors

Humer Novin Daroo Co.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 38 Years

Inclusion criteria

Inclusion criteria: Iranian female suffering infertility referring for IVF Age range: 18 - 38 years old Body Mass Index: 18 - 30 Kg/m2 Regular menstrual periods (25 - 35 days) Normal result based trans vaginal sonography at 2- 4 days of menstrual period at past 6 months Normal respondent to ovarian stimulating methods (10 -15 follicle with 3-8 mm diameter in two ovaries administering AFC or AMH more than 1.2 ng/mL in at least two cycles) Signing informed consent

Exclusion criteria

Exclusion criteria: Severe endometriosis (grade 3 or 4) Endocrine system impairments (Uncontrolled thyroid dysfunction, adrenal disease or uncorrected hyper-prolactinemia) Severe current smokers (more than 15 cigarette or 1 hookah per day) Previous hypersensitivity (e.g. OHSS) to Gonal-f or other FSH products Hepatic dysfunction (ALT or AST> 2 times the upper limit of normal) History of more than 2 unsuccessful IVF Any hormone therapy during past month (levothyroxine is exception) Azoospermia in husband confirmed by semen analysis History for suffering from any cancer Lactation during study History of previous uterine or ovarian surgery

Design outcomes

Primary

MeasureTime frame
The number of oocytes in MII phase at the day of oocyte retrieval. Timepoint: At the end of intervention. Method of measurement: Embryologic assessments.

Secondary

MeasureTime frame
The percent of mature oocyte in total oocytes retrieved. Timepoint: At the end of intervention. Method of measurement: Embryological assessment.;Total dose of administered rhFSH. Timepoint: At the end of intervention. Method of measurement: Patients' medical record.;Retrieved oocytes quality. Timepoint: At the end of intervention. Method of measurement: Embryological assessment.;Fertilization rate in oocytes. Timepoint: At the end of intervention. Method of measurement: Embryological assessment.;Chemical pregnancy. Timepoint: Two weeks after embryo transfer. Method of measurement: Beta HCG test.;Clinical pregnancy. Timepoint: 5-6 weeks after embryo transfer. Method of measurement: Ultrasonography.;Ovarian hyperstimulation syndrome (OHSS). Timepoint: During intervention. Method of measurement: Ultrasonography.;Thromboembolism. Timepoint: During intervention. Method of measurement: Clinical examination and patients record.;Unwanted serous events related to study medication. Timepoint: During and at the end of intervention. Method of measurement: Patients' medical records.;Embryo quality. Timepoint: At the end of intervention. Method of measurement: Embryological assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ramin Heshmat

Tehran University of Medical Sciences

rheshmat@tums.ac.ir+98 21 8822 0086

Outcome results

None listed

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