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

August 26, 2026 updated by: Oleksandr Plyh, LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro

Prospective Randomized Single-Blind Study of the Effectiveness of the Superovulation Stimulation Protocol Using hCG Compared to Standard Protocols With Different Gonadotropin Doses in In Vitro Fertilization Programs

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ovarian stimulation is a critical phase in assisted reproductive technologies (ART), but the high cost of recombinant gonadotropins remains a significant barrier to the accessibility of care for many patients. Human chorionic gonadotropin (hCG), due to its structural similarity to luteinizing hormone (LH), binds to LH/hCG receptors and can effectively support steroidogenesis and folliculogenesis when administered in sub-trigger doses. This prospective, randomized, single-blind trial is designed as a non-inferiority study to demonstrate that an hCG-based stimulation protocol is equivalent to standard controlled ovarian stimulation. While standard protocols rely on the continuous administration of follicle-stimulating hormone (FSH) or FSH/LH, the experimental protocol introduces 200 IU of hCG (without FSH) to replace standard gonadotropins once the main cohort of follicles reaches 11 to 12 millimeters in size. 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. Proving the non-inferiority of this alternative protocol could potentially reduce the medication cost of an IVF cycle by 30 to 60 percent, providing clinicians with a flexible, cost-effective tool without compromising clinical efficacy or patient safety.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Sali international school of fertility medicine
  • Ukraine
      • Chernivtsi, Ukraine
        • LTD "Yuzko" Yuzko Medical Center
      • Dnipro, Ukraine
        • LTD "EKODNIPRO" Medical Centre "Medical Plaza"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Presence of ovarian endometriomas.
  • History of severe Ovarian Hyperstimulation Syndrome (OHSS) in previous cycles.
  • Presence of severe endocrine disorders.
  • History or presence of oncological diseases.
  • Any medical contraindications to hormonal stimulation.
  • Severe male factor infertility (specifically cryptozoospermia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Other Names:
  • GnRH-agonist in case high risk of OHSS
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
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
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
Other Names:
  • GnRH-agonist in case high risk of OHSS
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved (oocyte yield)
Time Frame: Day of oocyte retrieval (typically 34-36 hours after trigger administration)
The total count of oocytes retrieved following the controlled ovarian stimulation protocol
Day of oocyte retrieval (typically 34-36 hours after trigger administration)
Proportion of Mature Oocytes (MII Rate)
Time Frame: Day of oocyte retrieval
Description: The percentage of retrieved oocytes that have reached the Metaphase II (MII) stage, evaluated according to the standardized ESHRE/ALPHA (Istanbul Consensus, 2025 update) criteria
Day of oocyte retrieval
Fertilization Rate
Time Frame: Day 1 following oocyte retrieval
The percentage of mature oocytes (MII) that are successfully fertilized.
Day 1 following oocyte retrieval
Embryo Quality
Time Frame: Day 3 and Day 5 following oocyte retrieval
The percentage of good quality cleavage-stage embryos and good quality blastocysts, assessed according to the standardized ESHRE/ALPHA (Istanbul Consensus, 2025 update) criteria.
Day 3 and Day 5 following oocyte retrieval
Total Dose of Gonadotropins/hCG
Time Frame: From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)
The total cumulative dose in International Units (IU) of gonadotropins or hCG administered throughout the entire stimulation cycle
From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy Rate
Time Frame: Approximately 4 to 6 weeks following embryo transfer
The percentage of patients who achieve a clinical pregnancy following embryo transfer
Approximately 4 to 6 weeks following embryo transfer
Live Birth Rate
Time Frame: Approximately 9 to 10 months following embryo transfer
The percentage of patients who achieve a live birth
Approximately 9 to 10 months following embryo transfer
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: From the day of trigger administration through the luteal phase/early pregnancy
The frequency of moderate and severe OHSS cases, classified according to RCOG/ESHRE criteria
From the day of trigger administration through the luteal phase/early pregnancy
Average Duration of Stimulation
Time Frame: From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)
The total number of days the stimulation medications were administered.
From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)
Endometrial Thickness
Time Frame: On the day of trigger administration
The thickness of the endometrium measured in millimeters (mm) via ultrasound
On the day of trigger administration
Cost of Stimulation Protocol per Cycle
Time Frame: At the completion of the stimulation protocol (day of trigger)
An economic evaluation calculating the total cost of all medications consumed during the stimulation cycle, initially recorded in UAH and converted to USD.
At the completion of the stimulation protocol (day of trigger)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LTD "Yuzko"

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oleksandr O. Plyh, MD, LTD "EKODNIPRO"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2 (Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in the final published article will be shared. This includes data collected for the primary and secondary endpoints, after appropriate anonymization to ensure strict compliance with GDPR and Ukrainian data protection laws.

IPD Sharing Time Frame

Data will become available beginning 6 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal to achieve aims outlined in the approved proposal. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a formal data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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