Multi-Site Cortical Puncture for DOR

Starting soon · Not applicable

Conditions studied: Diminished Ovarian Reserve (DOR)

In brief

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.

Key facts

Study ID

NCT07568639

Run by

First Affiliated Hospital of Guangxi Medical University

People needed

214

Starts

2026-04-30

Expected to finish

2030-12-30

Last updated by the study team

2026-05-06

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 20-45 years;
• 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).
• Patients scheduled for IVF (in vitro fertilization)/ICSI (intracytoplasmic sperm injection) treatment;
• 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;
• Bilateral follicles were observed during AFC examination;
• The planned ovarian stimulation protocol is one of PPOS, antagonist, or microstimulation protocols;
• The first ovulation induction protocol is planned to be consistent with the second ovulation induction protocol;
• Voluntary participation in the study and signing of the informed consent form.

You may not qualify if…

• 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;
• Patients with abnormal ovarian position who are expected to experience difficulties during oocyte retrieval puncture;
• 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);
• Patients with contraindications to hormone replacement therapy;
• Currently undergoing treatment with cytotoxic drugs, glucocorticoids or other immunosuppressants, radiotherapy or chemotherapy, or having previously received radiotherapy or chemotherapy;
• One spouse has chromosomal abnormalities;
• 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;
• Patients who have undergone oocyte retrieval or ovarian puncture within the past year;
• Participating in other clinical trials.

Where it is running

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

Full record on ClinicalTrials.gov

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