Multi-Site Cortical Puncture for DOR

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • multiple ovarian cortex punctures
  • routine oocyte retrieval procedure

Treatment groups

214 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital of Guangxi Medical University

Lead sponsor

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