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Multi-Site Cortical Puncture for DOR (MSCPD)

28 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

214

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.

Coordonnées de l'étude

  • Nom: Yihua Yang, Doctor
  • Numéro de téléphone: 86-0771-5356126
  • E-mail: workyyh@163.com

Lieux d'étude

  • Chine
    • Fujian
      • Xiamen, Fujian, Chine
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Guangxi
      • Guigang, Guangxi, Chine
        • Guigang City People'S Hospital
        • Contact:
      • Liuzhou, Guangxi, Chine
        • Liuzhou People's Hospital
        • Contact:
      • Nanning, Guangxi, Chine
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • hua Yi Yang
          • Numéro de téléphone: 86-0771-5356126
          • E-mail: workyyh@163.com
      • Nanning, Guangxi, Chine
        • The Second Nanning People's Hospital
        • Contact:
      • Nanning, Guangxi, Chine, 530011
        • Nanning Maternity and Child Health Care Hospital
        • Contact:
      • Qinzhou, Guangxi, Chine
        • Qinzhou Maternity and Child Health Care Hospital
        • Contact:

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:

  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.

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: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: 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).
Autre: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of oocytes retrieved during the second ovarian stimulation cycle
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Key reproductive-related indicators for the second ovarian stimulation and oocyte retrieval cycle
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

First Affiliated Hospital of Guangxi Medical University

Collaborateurs

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

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 (Estimé)

30 avril 2026

Achèvement primaire (Estimé)

30 mars 2028

Achèvement de l'étude (Estimé)

30 décembre 2030

Dates d'inscription aux études

Première soumission

12 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 avril 2026

Dernière vérification

1 mars 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • YYZS2021001002
  • YYZS2021001 (Autre subvention/numéro de financement: The First Affiliated Hospital of Guangxi Medical University)

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

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 .

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