Purpose to Evaluate the Effectiveness of the Superovulation Stimulation Protocol Using Human Chorionic Gonadotropin (hCG) by Demonstrating Its Equivalence to Standard Controlled Ovarian Stimulation Protocols in Terms of Oocytes Retrieved, Blastulation While Maintaining an Economic Advantage

Summary

This study evaluates a more affordable medication protocol for ovarian stimulation during in vitro fertilization (IVF). Standard IVF protocols use medications called gonadotropins to stimulate the ovaries to produce multiple eggs, but these medications can be very expensive and create a barrier to treatment. This clinical trial tests whether substituting a significant portion of these standard medications with human chorionic gonadotropin (hCG) is just as effective. Researchers will compare the number and quality of eggs and embryos produced by women using the experimental hCG protocol versus those using the standard gonadotropin protocol. The main goal is to determine if the hCG method can provide similar clinical outcomes and safety profiles while significantly reducing the overall financial cost of IVF treatment.

Conditions

• Infertility (IVF Patients)
• Infertility Assisted Reproductive Technology
• Infertile Patients
• Infertility Drugs
• Infertile Women Undergoing IVF or ICSI
• Infertility
• Stimulation in the Ovary
• Infertile Women Undergoing ART
• Controlled Ovarian Simulation
• Infertile Women Undergoing Assisted Reproductive Technology (ART)

Interventions

DRUG

Human Chorionic Gonadotropin (hCG)

Administered in sub-trigger doses of 200 IU (without FSH) as a substitute for LH activity and to support folliculogenesis

DRUG

GnRH antagonist

Administered starting on the 6th day of stimulation as part of a fixed antagonist protocol

DRUG

Dual trigger (human chorionic gonadotropin plus GnRH-agonist)

Administered to induce final oocyte maturation before retrieval

DRUG

Gonadotropins (FSH or FSH/LH)

Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day.

DRUG

Gonadotropins (FSH or FSH/LH)

Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day before main cohort of follicles reach size 11-12mm

Sponsors & Collaborators

• LTD "Yuzko"

  collaborator UNKNOWN

• LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro

  lead OTHER

Principal Investigators

• Oleksandr O. Plyh, MD · LTD "EKODNIPRO"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-17

Primary Completion

2028-02-01

Completion

2028-05-01

Countries

• Uganda
• Ukraine

Study Locations