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
2026年8月26日 更新者: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.
調査の概要
状態
招待による登録
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
360
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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
他の名前:
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
|
|
アクティブコンパレータ: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
他の名前:
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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of oocytes retrieved (oocyte yield)
時間枠: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)
時間枠: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
時間枠:Day 1 following oocyte retrieval
|
The percentage of mature oocytes (MII) that are successfully fertilized.
|
Day 1 following oocyte retrieval
|
|
Embryo Quality
時間枠: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
時間枠: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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Pregnancy Rate
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者:Oleksandr O. Plyh, MD、LTD "EKODNIPRO"
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月17日
一次修了 (推定)
2028年2月1日
研究の完了 (推定)
2028年5月1日
試験登録日
最初に提出
2026年8月10日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月27日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2 (Instituto Cardiovascular de Buenos Aires)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Data will become available beginning 6 months and ending 36 months following article publication.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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