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Multi-Site Cortical Puncture for DOR (MSCPD)

28 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

214

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Yihua Yang, Doctor
  • Numero di telefono: 86-0771-5356126
  • Email: workyyh@163.com

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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).
Altro: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of oocytes retrieved during the second ovarian stimulation cycle
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Key reproductive-related indicators for the second ovarian stimulation and oocyte retrieval cycle
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 aprile 2026

Completamento primario (Stimato)

30 marzo 2028

Completamento dello studio (Stimato)

30 dicembre 2030

Date di iscrizione allo studio

Primo inviato

12 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • YYZS2021001002
  • YYZS2021001 (Altro numero di sovvenzione/finanziamento: The First Affiliated Hospital of Guangxi Medical University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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