Multi-Site Cortical Puncture for DOR

NCT07568639 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Guangxi Medical University

Phase

Not applicable

Started

2026-04-30

Last updated

2026-05-06

Condition(s) studied

Diminished Ovarian Reserve (DOR)

Investigational drug(s) / intervention(s)

multiple ovarian cortex puncturesroutine oocyte retrieval procedure

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).

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.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

45 Years

Healthy volunteers

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.

Primary outcome measure(s)

Number of oocytes retrieved during the second ovarian stimulation cycle — 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).

Trial sites (7)

Facility	City	Region
The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
Guigang City People's Hospital	Guigang	Guangxi
Liuzhou People's Hospital	Liuzhou	Guangxi
Nanning Maternity and Child Health Care Hospital	Nanning	Guangxi
The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
The Second Nanning People's Hospital	Nanning	Guangxi
Qinzhou Maternity and Child Health Care Hospital	Qinzhou	Guangxi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07568639 on ClinicalTrials.gov ↗ ← All trials in China