An interventional study of Human Chorionic Gonadotropin (hCG) and GnRH antagonist in Infertility (IVF Patients), Infertility Assisted Reproductive Technology and Infertile Patients, sponsored by LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro. Enrolling by invitation at 3 sites in 2 countries. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro · Not applicable, Interventional, and Treatment
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.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 360 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →This is the only study on the registry with LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Drug: GnRH antagonist · Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist) · Drug: Gonadotropins (FSH or FSH/LH)
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 · Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist) · Drug: Gonadotropins (FSH or FSH/LH)
Administered in sub-trigger doses of 200 IU (without FSH) as a substitute for LH activity and to support folliculogenesis
Administered starting on the 6th day of stimulation as part of a fixed antagonist protocol
Administered to induce final oocyte maturation before retrieval
Also known as: GnRH-agonist in case high risk of OHSS
Drug page: Gonadotropins
Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day.
Drug page: Gonadotropins
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
Number of oocytes retrieved (oocyte yield)
The total count of oocytes retrieved following the controlled ovarian stimulation protocol
Time frame: Day of oocyte retrieval (typically 34-36 hours after trigger administration)
Proportion of Mature Oocytes (MII Rate)
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
Time frame: Day of oocyte retrieval
Fertilization Rate
The percentage of mature oocytes (MII) that are successfully fertilized.
Time frame: Day 1 following oocyte retrieval
Embryo Quality
The percentage of good quality cleavage-stage embryos and good quality blastocysts, assessed according to the standardized ESHRE/ALPHA (Istanbul Consensus, 2025 update) criteria.
Time frame: Day 3 and Day 5 following oocyte retrieval
Total Dose of Gonadotropins/hCG
The total cumulative dose in International Units (IU) of gonadotropins or hCG administered throughout the entire stimulation cycle
Time frame: From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)
Clinical Pregnancy Rate
The percentage of patients who achieve a clinical pregnancy following embryo transfer
Time frame: Approximately 4 to 6 weeks following embryo transfer
Live Birth Rate
The percentage of patients who achieve a live birth
Time frame: Approximately 9 to 10 months following embryo transfer
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
The frequency of moderate and severe OHSS cases, classified according to RCOG/ESHRE criteria
Time frame: From the day of trigger administration through the luteal phase/early pregnancy
Average Duration of Stimulation
The total number of days the stimulation medications were administered.
Time frame: From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)
Endometrial Thickness
The thickness of the endometrium measured in millimeters (mm) via ultrasound
Time frame: On the day of trigger administration
Cost of Stimulation Protocol per Cycle
An economic evaluation calculating the total cost of all medications consumed during the stimulation cycle, initially recorded in UAH and converted to USD.
Time frame: At the completion of the stimulation protocol (day of trigger)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: Data will become available beginning 6 months and ending 36 months following article publication.
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.
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Studies of the drug tested here: Chorionic Gonadotropin