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 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
- Infertilité
- Femmes infertiles subissant une FIV ou une ICSI
- Simulation ovarienne contrôlée
- Infertilité
- Infertilité (patientes FIV)
- Femmes infertiles subissant une technologie de procréation assistée (ART)
- Stimulation dans l'ovaire
- Technologie de procréation assistée en cas d'infertilité
- Patients infertiles
- Infertile Women Undergoing ART
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
360
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La 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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
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
|
|
Comparateur actif: 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
Autres noms:
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of oocytes retrieved (oocyte yield)
Délai: 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)
Délai: 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
Délai: Day 1 following oocyte retrieval
|
The percentage of mature oocytes (MII) that are successfully fertilized.
|
Day 1 following oocyte retrieval
|
|
Embryo Quality
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Pregnancy Rate
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Oleksandr O. Plyh, MD, LTD "EKODNIPRO"
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 août 2026
Achèvement primaire (Estimé)
1 février 2028
Achèvement de l'étude (Estimé)
1 mai 2028
Dates d'inscription aux études
Première soumission
10 août 2026
Première soumission répondant aux critères de contrôle qualité
14 août 2026
Première publication (Réel)
18 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies génitales, femme
- Infertilité
- Infertilité féminine
- Hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Hormones de libération d'hormones hypophysaires
- Hormones hypothalamiques
- Hormones peptidiques
- Neuropeptides
- Peptides
- Acides aminés, peptides et protéines
- Oligopeptides
- Protéines de tissu nerveux
- Protéines
- Hormones placentaires
- Protéines de grossesse
- Gonadotrophine chorionique
- Hormone de libération de la gonadotrophine
- LHRH, AC-NAL (1) -CPA (2) -TRP (3) -ARG (6) -ALA (10) -
- Gonadotropins
Autres numéros d'identification d'étude
- 2 (Instituto Cardiovascular de Buenos Aires)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Data will become available beginning 6 months and ending 36 months following article publication.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .