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

Sponsor
LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro
Study ID
NCT07771283
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Human Chorionic Gonadotropin (hCG) — DRUG
    Administered in sub-trigger doses of 200 IU (without FSH) as a substitute for LH activity and to support folliculogenesis
  • GnRH antagonist — DRUG
    Administered starting on the 6th day of stimulation as part of a fixed antagonist protocol
  • Dual trigger (human chorionic gonadotropin plus GnRH-agonist) — DRUG
    Administered to induce final oocyte maturation before retrieval
  • Gonadotropins (FSH or FSH/LH) — DRUG
    Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day.
  • Gonadotropins (FSH or FSH/LH) — DRUG
    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

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Aug 17, 2026
Status verified
Aug 2026
Primary completion
Feb 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: hCG Protocol
    atients in this group undergo ovarian stimulation where human chorionic gonadotropin (hCG) replaces standard gonadotropins (or a significant portion of them) once the main cohort of follicles reaches 11-12 mm in size. This arm utilizes a fixed gonadotropin-releasing hormone (GnRH) antagonist protocol starting on day 6 of stimulation and a dual trigger for final maturation.
  • Active Comparator: Standard Protocol
    Patients in this group undergo standard controlled ovarian stimulation using continuous administration of gonadotropins. This arm also utilizes a fixed gonadotropin-releasing hormone (GnRH) antagonist protocol starting on day 6 of stimulation and a dual trigger for final maturation

Primary Outcome Measure

Number of oocytes retrieved (oocyte yield) [ Time Frame: Day of oocyte retrieval (typically 34-36 hours after trigger administration) ]

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