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

What Was Tested

The trial (not phased) is built around hCG (human chorionic gonadotropin).

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.

It had two arms (groups): hCG Protocol (experimental) and Standard Protocol (active comparator).

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.

The registry classes the interventions as drug.

More on the Plan

Both treatment arms will utilize a fixed gonadotropin-releasing hormone (GnRH) antagonist protocol starting on day 6 of stimulation, followed by a dual trigger for final oocyte maturation.

To minimize bias and ensure objective results, the embryologists evaluating oocyte morphology, fertilization rates, and blastocyst development will be blinded to the treatment arm assignments.

If moderate or severe ovarian hyperstimulation syndrome (OHSS) is suspected in the experimental group, the protocol incorporates safety measures, including switching to a GnRH agonist trigger and utilizing a "freeze-all" strategy.

By thoroughly comparing these methods through both intention-to-treat (ITT) and per-protocol (PP) analyses, researchers aim to validate an individualized treatment approach.

Who Took Part

The registry lists 360 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women of reproductive age between 18 and 40 years. Clinical indications for the induction of superovulation (undergoing ART/IVF programs). Patients with all variants of ovarian reserve. Body Mass Index (BMI) up to 35 kg/m². Provision of informed consent to participate in the research study.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: presence of ovarian endometriomas; history of severe ovarian hyperstimulation syndrome (ohss) in previous cycles; presence of severe endocrine disorders.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-08-17 with completion listed for 2028-02-01.

It ran at 3 sites in Ukraine (2) and Uganda (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of oocytes retrieved (oocyte yield) (time frame: Day of oocyte retrieval (typically 34-36 hours after trigger administration)). Proportion of Mature Oocytes (MII Rate) (time frame: Day of oocyte retrieval). Fertilization Rate (time frame: Day 1 following oocyte retrieval).

It also tracked 6 secondary outcomes, for example Clinical Pregnancy Rate, Live Birth Rate, Incidence of Ovarian Hyperstimulation Syndrome (OHSS), Average Duration of Stimulation, Endometrial Thickness and Cost of Stimulation Protocol per Cycle.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 360 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.