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Multi-Site Cortical Puncture for DOR (MSCPD)

28. dubna 2026 aktualizováno: First Affiliated Hospital of Guangxi Medical University

Clinical Efficacy and Safety of Multiple Ovarian Cortex Punctures in Improving Ovarian Reserve and Ovarian Stimulation Outcomes in Patients With Diminished Ovarian Reserve (DOR): A Multicenter, Prospective, Randomized Controlled Clinical Trial

A multicenter, prospective, randomized controlled clinical trial. The target population consists of patients undergoing IVF/ICSI artificial reproduction who plan to undergo ovarian stimulation and embryo retrieval (DOR) within 4 months. A stratified block randomization method was employed to assign participants in a 1:1 ratio to the intervention group and control group. The study aims to investigate whether multiple-point ovarian cortex puncture during the initial oocyte retrieval procedure improves ovarian reserve and ovarian stimulation outcomes in DOR patients compared to conventional oocyte retrieval techniques.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This is a multicenter, prospective, randomized controlled clinical trial designed to evaluate the efficacy of ovarian cortex multi-point puncture in improving ovarian reserve and ovarian stimulation outcomes in patients with delayed ovarian reserve (DOR). The target population consists of DOR patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) with plans for subsequent ovarian stimulation and embryo retrieval within 4 months. The primary objective is to assess whether ovarian cortex multi-point puncture during the initial oocyte retrieval procedure improves ovarian reserve and ovarian stimulation outcomes compared to conventional oocyte retrieval. The study plans to continuously recruit 214 participants across seven participating centers.

The study period for the research subjects comprises three phases: screening and baseline phase, intervention phase, and follow-up phase.

During the screening and baseline phase, patients scheduled for IVF/ICSI artificial reproduction with plans to undergo ovarian stimulation, oocyte retrieval, embryo transfer, and DOR within 4 months were invited to participate in this study. Written informed consent forms were provided to potential participants, with detailed explanations of the study protocol. Prior to implementing any specific study procedures, written informed consent from participants (or their legal representatives) was obtained. After signing the informed consent form, participants were randomly assigned to the intervention group or control group using a stratified block randomization method (with research centers as stratification factors) at a 1:1 ratio, followed by baseline data collection.

During the intervention period, on the day of oocyte retrieval after the first ovarian stimulation cycle, the control group underwent conventional anesthesia (intravenous anesthesia or sedation) followed by standard oocyte retrieval procedures according to institutional protocols. A standard 17G double-lumen oocyte retrieval needle was used with transvaginal ultrasound guidance and puncture guide frame. The intervention group completed conventional oocyte retrieval under the same anesthesia/sedation conditions and immediately underwent ovarian cortical multi-point puncture under ultrasound guidance (without needle replacement). The procedure involved selecting the ovary with relatively fewer follicles larger than 14mm and establishing two evenly distributed puncture sites in the cortical region. For patients requiring continued ovarian stimulation therapy prior to the second oocyte retrieval, the ovarian stimulation protocol remained consistent with the previous cycle. Detailed records were maintained for the stimulation regimen, medication dosages, oocyte retrieval puncture documentation, and adverse event occurrences.

During the follow-up period, study subjects undergoing IVF/ICSI treatment were monitored for pregnancy outcomes (biochemical pregnancy rate, implantation rate, clinical pregnancy rate, miscarriage rate (early ≤12 weeks and mid-to-late <28 weeks), live birth rate, cumulative pregnancy rate, cumulative live birth rate), neonatal outcomes (preterm birth, stillbirth, low birth weight infants, birth defects), and adverse event-related data.

Typ studie

Intervenční

Zápis (Odhadovaný)

214

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Yihua Yang, Doctor
  • Telefonní číslo: 86-0771-5356126
  • E-mail: workyyh@163.com

Studijní místa

  • Čína
    • Fujian
      • Xiamen, Fujian, Čína
        • The First Affiliated Hospital of Xiamen University
        • Kontakt:
    • Guangxi
      • Guigang, Guangxi, Čína
        • Guigang City People's Hospital
        • Kontakt:
      • Liuzhou, Guangxi, Čína
        • Liuzhou People's Hospital
        • Kontakt:
      • Nanning, Guangxi, Čína
        • The First Affiliated Hospital of Guangxi Medical University
        • Kontakt:
      • Nanning, Guangxi, Čína
        • The Second Nanning People's Hospital
        • Kontakt:
      • Nanning, Guangxi, Čína, 530011
        • Nanning Maternity and Child Health Care Hospital
        • Kontakt:
      • Qinzhou, Guangxi, Čína
        • Qinzhou Maternity and Child Health Care Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Age 20-45 years;
  2. Infertile women meeting the diagnostic criteria for diminished ovarian reserve (DOR); The following two criteria must be met simultaneously: ① Anti-Müllerian hormone (AMH) ≤0.5 ng/ml, ② Bilateral ovarian antral follicles (AFC) ≤5 (3-9 mm).
  3. Patients scheduled for IVF (in vitro fertilization)/ICSI (intracytoplasmic sperm injection) treatment;
  4. Patients who plan for whole embryo cryopreservation and intend to undergo another ovulation induction cycle within 4 natural months starting from the first cycle, with the goal of embryo retrieval and embryo banking;
  5. Bilateral follicles were observed during AFC examination;
  6. The planned ovarian stimulation protocol is one of PPOS, antagonist, or microstimulation protocols;
  7. The first ovulation induction protocol is planned to be consistent with the second ovulation induction protocol;
  8. Voluntary participation in the study and signing of the informed consent form.

Exclusion Criteria:

  1. Patients with the following reproductive and gynecological comorbidities: history of salpingectomy, ovarian cysts (e.g., chocolate cysts), ovarian tumors, or simple cysts ≥10 mm (not eligible for enrollment in the current cycle; may be enrolled after regression), history of ovarian surgery, endometriosis or adenomyosis, or acute pelvic inflammatory disease;
  2. Patients with abnormal ovarian position who are expected to experience difficulties during oocyte retrieval puncture;
  3. Patients with concomitant systemic severe diseases (history of severe chronic diseases such as heart failure, myocardial infarction, stroke, end-stage renal disease; advanced cancer or other terminal illnesses with an estimated survival period of less than 6 months; coagulation disorders; uncontrolled sepsis; autoimmune diseases; poor general condition rendering anesthesia and surgery intolerable);
  4. Patients with contraindications to hormone replacement therapy;
  5. Currently undergoing treatment with cytotoxic drugs, glucocorticoids or other immunosuppressants, radiotherapy or chemotherapy, or having previously received radiotherapy or chemotherapy;
  6. One spouse has chromosomal abnormalities;
  7. Patients with a history of uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders, where the investigator determines that clinical severity affects compliance with the clinical study;
  8. Patients who have undergone oocyte retrieval or ovarian puncture within the past year;
  9. Participating in other clinical trials.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: intervention group (multiple ovarian cortex puncture)
The intervention group underwent combined ovarian cortex multi-point puncture in addition to conventional oocyte retrieval procedures (identical to the control group). Specifically, after completing standard oocyte retrieval under the same anesthesia/sedation conditions, multi-point ovarian cortex puncture was performed without needle replacement. The procedure was guided by real-time ultrasound to ensure operational accuracy and visualization. On ultrasound imaging, three puncture sites were selected from the ovarian cortex region (avoiding residual follicles, corpus luteum, and medullary vascular areas) for uniform distribution: the first puncture point was aligned with the oocyte retrieval puncture line, followed by the second and third puncture points located approximately 5 mm to either side of the first point after exiting the ovarian surface.
Postup: multiple ovarian cortex punctures
During the intervention period, on the day of oocyte retrieval after the first ovarian stimulation cycle, the control group underwent conventional anesthesia (intravenous anesthesia or sedation) followed by standard oocyte retrieval procedures according to institutional protocols. A standard 17G double-lumen oocyte retrieval needle was used with transvaginal ultrasound guidance and puncture guide frame. The intervention group completed conventional oocyte retrieval under the same anesthesia/sedation conditions and immediately underwent ovarian cortical multi-point puncture under ultrasound guidance (without needle replacement).
Jiný: control group (conventional oocyte retrieval procedure)
Control measures (routine oocyte retrieval procedure):The procedure was performed according to the standard oocyte retrieval protocols of each center, with ovarian follicle aspiration completed under transvaginal ultrasound guidance. All target follicles were confirmed to have undergone complete aspiration of follicular fluid.
Jiný: routine oocyte retrieval procedure
Equipment preparation:Oocyte retrieval puncture needle(Standard 17G double-lumen oocyte retrieval needle),Transvaginal ultrasound probe and puncture guidance frame, Sterile gloves, disinfectant solution, sterile gauze; Patient Preparation:Verify patient identity,Routine pre-oocyte retrieval preparations (bladder emptying, vulvar disinfection, etc.),Anesthesia method: According to the standard practice of each center (intravenous anesthesia or sedation); Oocyte retrieval procedure (identical in both groups):The procedure was performed according to the standard oocyte retrieval protocols of each center, with ovarian follicle aspiration completed under transvaginal ultrasound guidance. All target follicles were confirmed to have undergone complete aspiration of follicular fluid.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of oocytes retrieved during the second ovarian stimulation cycle
Časové okno: The assessment period lasts up to 4 months, from the date of randomization to the completion of the second ovarian stimulation and oocyte retrieval.
Number of oocytes retrieved during the second ovarian stimulation cycle in DOR patients (recorded separately by investigators unaware of group assignments for left and right ovaries).
The assessment period lasts up to 4 months, from the date of randomization to the completion of the second ovarian stimulation and oocyte retrieval.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Key reproductive-related indicators for the second ovarian stimulation and oocyte retrieval cycle
Časové okno: From the date of randomization to the third month after the second ovulation induction and oocyte retrieval surgery, the assessment period can last up to 7 months.
Antral follicle count (AFC), anti-Müllerian hormone (AMH), number of follicles ≥14mm on HCG day, number of MII-stage follicles, number of fertilizations, number of 2pn embryos, number of embryos, and number of high-quality embryos;
From the date of randomization to the third month after the second ovulation induction and oocyte retrieval surgery, the assessment period can last up to 7 months.
Rate of biochemical pregnancy
Časové okno: From the date of randomization to the occurrence of biochemical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
A blood pregnancy test is performed 14 days after embryo transfer. A positive result is defined as biochemical pregnancy. The rate of biochemical pregnancy is calculated using the following formula: (Number of cycles with positive blood hCG / Number of transfer cycles) × 100%.
From the date of randomization to the occurrence of biochemical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
Clinical pregnancy rate
Časové okno: From the date of randomization to clinical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
Transvaginal ultrasound examination performed 4-5 weeks after embryo transfer is conducted. If intrauterine gestational sac, ectopic pregnancy, or combined intrauterine and extrauterine pregnancy is detected, it is classified as clinical pregnancy. The clinical pregnancy rate is calculated using the following formula: (Number of cycles with clinical pregnancy / Total number of embryo transfer cycles) × 100%.
From the date of randomization to clinical pregnancy after this embryo transfer, the assessment period can last up to 24 months.
Implantation rate
Časové okno: From the date of randomization to implantation at the 5th week after embryo transfer, the assessment period can last up to 24 months.
Transvaginal ultrasound examination performed 4-5 weeks after embryo transfer. If intrauterine or ectopic gestational sacs are detected, implantation is confirmed. (Number of gestational sacs / Number of transferred embryos) × 100%
From the date of randomization to implantation at the 5th week after embryo transfer, the assessment period can last up to 24 months.
Abortion rate
Časové okno: From the date of randomization to miscarriage after this embryo transfer, the assessment period can last up to 30 months.
Early abortion rate (number of cycles with miscarriage occurring before 12 weeks / total clinical pregnancy cycles) × 100%; Mid-to-late abortion rate (number of cycles with miscarriage occurring between 12 weeks and 28 weeks / total clinical pregnancy cycles) × 100%.
From the date of randomization to miscarriage after this embryo transfer, the assessment period can last up to 30 months.
Live birth rate
Časové okno: From the date of randomization to the birth of a full-term live fetus following this embryo transfer, the assessment period lasts up to 36 months.
(Number of transplant cycles achieving at least one full-term live birth at 28 weeks / Total number of transplant cycles) × 100%
From the date of randomization to the birth of a full-term live fetus following this embryo transfer, the assessment period lasts up to 36 months.
Cumulative pregnancy rate
Časové okno: From the date of randomization to clinical pregnancy after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
The proportion of patients who ultimately achieve clinical pregnancy, calculated until all transplantable embryos obtained from two consecutive IVF/ICSI cycles are exhausted.
From the date of randomization to clinical pregnancy after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
Cumulative live birth rate
Časové okno: From the date of randomization to the birth of a full-term live fetus after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
The proportion of patients who ultimately achieved live births (gestation ≥28 weeks) using transplantable embryos obtained from two consecutive IVF/ICSI cycles until all embryos were exhausted.
From the date of randomization to the birth of a full-term live fetus after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.
Adverse neonatal outcomes
Časové okno: From the date of randomization to one year after the birth of the newborn, the assessment period can last up to 100 months.
primarily including preterm birth, stillbirth, low birth weight infants, and birth defects;
From the date of randomization to one year after the birth of the newborn, the assessment period can last up to 100 months.
Incidence of adverse events
Časové okno: From the date of randomization to the date of adverse event occurrence, the assessment period lasts up to 100 months.
Adverse events and serious adverse events, with a focus on evaluating the incidence of puncture-related adverse events (e.g., bleeding, injury, infection).
From the date of randomization to the date of adverse event occurrence, the assessment period lasts up to 100 months.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

First Affiliated Hospital of Guangxi Medical University

Spolupracovníci

Nanjing Maternity and Child Health Care Hospital
The First Affiliated Hospital of Xiamen University
LiuZhou People's Hospital
The second Nanning People's Hospital
Qinzhou Maternity and Child Health Care Hospital
Guigang city People's Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. dubna 2026

Primární dokončení (Odhadovaný)

30. března 2028

Dokončení studie (Odhadovaný)

30. prosince 2030

Termíny zápisu do studia

První předloženo

12. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

28. dubna 2026

První zveřejněno (Aktuální)

6. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. dubna 2026

Naposledy ověřeno

1. března 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • YYZS2021001002
  • YYZS2021001 (Jiné číslo grantu/financování: The First Affiliated Hospital of Guangxi Medical University)

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