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ClinicalTrials.gov ID

NCT07568639

Lead Sponsor

First Affiliated Hospital of Guangxi Medical UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

214Estimated

Last Update Posted

May 6, 2026Actual

Start Date

Apr 30, 2026Estimated

Primary Completion Date

Mar 30, 2028Estimated

Completion Date

Dec 30, 2030Estimated

Official Title

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

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.

Detailed Description

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.

• Diminished Ovarian Reserve (DOR)

• multiple ovarian cortex punctures
• routine oocyte retrieval procedure

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

First Affiliated Hospital of Guangxi Medical UniversityOTHER

Collaborators

Nanjing Maternity and Child Health Care HospitalOTHER

Qinzhou Maternity and Child Health Care HospitalUNKNOWN

The First Affiliated Hospital of Xiamen UniversityOTHER

Guigang city People's HospitalUNKNOWN

LiuZhou People's HospitalOTHER

Nanning Second People's HospitalOTHER

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