Multi-Site Cortical Puncture for DOR

NCT07568639 | Not Yet Recruiting

• 2 other identifiers: YYZS2021001002YYZS2021001
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Diminished Ovarian Reserve (DOR)

Keywords

Diminished ovarian reserve (DOR); RCT; cortex punctures

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved during the second ovarian stimulation cycle

  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.

Secondary Outcomes (10)

• Key reproductive-related indicators for the second ovarian stimulation and oocyte retrieval cycle

  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

  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

  From the date of randomization to clinical pregnancy after this embryo transfer, the assessment period can last up to 24 months.

• Implantation rate

  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

  From the date of randomization to miscarriage after this embryo transfer, the assessment period can last up to 30 months.

Study Arms (2)

intervention group (multiple ovarian cortex puncture)

EXPERIMENTAL

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.

Procedure: multiple ovarian cortex punctures

control group (conventional oocyte retrieval procedure)

OTHER

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.

Other: routine oocyte retrieval procedure

Interventions

routine oocyte retrieval procedure OTHER

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.

control group (conventional oocyte retrieval procedure)

multiple ovarian cortex punctures PROCEDURE

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).

intervention group (multiple ovarian cortex puncture)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead
• Nanjing Maternity and Child Health Care Hospital: collaborator
• Qinzhou Maternity and Child Health Care Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Guigang city People's Hospital: collaborator
• LiuZhou People's Hospital: collaborator
• The second Nanning People's Hospital: collaborator

Study Sites (7)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Guigang City People's Hospital

Guigang, Guangxi, China

Location

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Location

Nanning Maternity and Child Health Care Hospital

Nanning, Guangxi, 530011, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

The Second Nanning People's Hospital

Nanning, Guangxi, China

Location

Qinzhou Maternity and Child Health Care Hospital

Qinzhou, Guangxi, China

Location

Central Study Contacts

Yihua Yang, Doctor

CONTACT

86-0771-5356126; workyyh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 6, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-03

Locations

CN (7)