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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

26. august 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

360

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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
Andre navn:
  • GnRH-agonist in case high risk of OHSS
Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day.
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
Aktiv komparator: 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
Administered starting on the 6th day of stimulation as part of a fixed antagonist protocol
Administered to induce final oocyte maturation before retrieval
Andre navn:
  • GnRH-agonist in case high risk of OHSS
Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day.
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of oocytes retrieved (oocyte yield)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Day 1 following oocyte retrieval
The percentage of mature oocytes (MII) that are successfully fertilized.
Day 1 following oocyte retrieval
Embryo Quality
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Pregnancy Rate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Oleksandr O. Plyh, MD, LTD "EKODNIPRO"

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. august 2026

Primær fullføring (Antatt)

1. februar 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

10. august 2026

Først innsendt som oppfylte QC-kriteriene

14. august 2026

Først lagt ut (Faktiske)

18. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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