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 aktualisiert von: 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.
Studienübersicht
Status
Anmeldung auf Einladung
Bedingungen
- Unfruchtbarkeit
- Unfruchtbare Frauen, die sich einer IVF oder ICSI unterziehen
- Kontrollierte Eierstocksimulation
- Unfruchtbarkeitsmedikamente
- Unfruchtbarkeit (IVF-Patienten)
- Unfruchtbare Frauen, die sich einer assistierten Reproduktionstechnologie (ART) unterziehen
- Stimulation im Eierstock
- Unfruchtbarkeitsunterstützte Reproduktionstechnologie
- Unfruchtbare Patienten
- Infertile Women Undergoing ART
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
360
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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
Andere Namen:
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
|
|
Aktiver 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
Andere Namen:
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of oocytes retrieved (oocyte yield)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Day 1 following oocyte retrieval
|
The percentage of mature oocytes (MII) that are successfully fertilized.
|
Day 1 following oocyte retrieval
|
|
Embryo Quality
Zeitfenster: 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
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinical Pregnancy Rate
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Oleksandr O. Plyh, MD, LTD "EKODNIPRO"
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.
- Huong NTL, Thuy TT, Anh PTT, Long HB, Thang LD, Ngoc VT, Do LQ, Duy NXA, Hanh BT, Loi DV, Hoang L. Effects of 100 IU versus 150 IU hCG supplementation on oocyte and embryo quality in patients aged >/= 35 years: a propensity score-matched analysis. Int J Med Sci. 2025 Jan 27;22(4):982-989. doi: 10.7150/ijms.106965. eCollection 2025.
- Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.
- Lin H, Huang X, Zhao Y, Wang Y, Wang S, Hong F, Pan M, Liu L. Low-dose human chorionic gonadotropin supplementation initiated at the onset of ovarian stimulation can improve oocyte quality without impairing endometrial receptivity: Case series. Medicine (Baltimore). 2022 Dec 2;101(48):e32175. doi: 10.1097/MD.0000000000032175.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
17. August 2026
Primärer Abschluss (Geschätzt)
1. Februar 2028
Studienabschluss (Geschätzt)
1. Mai 2028
Studienanmeldedaten
Zuerst eingereicht
10. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. August 2026
Zuerst gepostet (Tatsächlich)
18. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Genitalerkrankungen, weiblich
- Unfruchtbarkeit
- Unfruchtbarkeit, weiblich
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Hypophysenhormon-Freisetzungshormone
- Hypothalamische Hormone
- Peptidhormone
- Neuropeptide
- Peptide
- Aminosäuren, Peptide und Proteine
- Oligopeptide
- Nervengewebeproteine
- Proteine
- Plazentahormone
- Schwangerschaftsproteine
- Choriongonadotropin
- Gonadotropin-freisetzendes Hormon
- LHRH, AC-NAL (1) -CPA (2) -TRP (3) -Arg (6) -Ala (10)-
- Gonadotropins
Andere Studien-ID-Nummern
- 2 (Instituto Cardiovascular de Buenos Aires)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Zeitrahmen
Data will become available beginning 6 months and ending 36 months following article publication.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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