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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

2026년 8월 26일 업데이트: 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.

연구 개요

상태

초대로 등록

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

360

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
다른 이름들:
  • 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
활성 비교기: 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
다른 이름들:
  • 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of oocytes retrieved (oocyte yield)
기간: 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)
기간: 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
기간: Day 1 following oocyte retrieval
The percentage of mature oocytes (MII) that are successfully fertilized.
Day 1 following oocyte retrieval
Embryo Quality
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Clinical Pregnancy Rate
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Oleksandr O. Plyh, MD, LTD "EKODNIPRO"

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 17일

기본 완료 (추정된)

2028년 2월 1일

연구 완료 (추정된)

2028년 5월 1일

연구 등록 날짜

최초 제출

2026년 8월 10일

QC 기준을 충족하는 최초 제출

2026년 8월 14일

처음 게시됨 (실제)

2026년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 26일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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