The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This randomized controlled trial aims to determine whether Erzhi Tiangui Formula can optimize the reproductive outcomes of elderly patients with expected poor ovarian response, and to provide a new approach to traditional Chinese medicine assisted in vitro fertilization and embryo transfer (IVF-ET).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shandong University of Traditional Chinese Medicine
• Collaborators: Chongqing Medical Center for Women and Children; First Affiliated Hospital of Wenzhou Medical University; Hospital for Reproductive Medicine Affiliated to Shandong University; Maternal and Child Health Care Hospital of Shandong Province; Maternity and Child Health Care of Zaozhuang; Shanxi Provincial Maternity and Children's Hospital; The 960th Hospital of the PLA Joint Logistics Support Force; The Second Hospital of Hebei Medical University; Yantai Shan Hospital

Criteria

Inclusion Criteria:

• Women under 42 years of age with a poor ovarian response (according to the Bologna criteria) .

Exclusion Criteria:

• Individuals with a Body Mass Index (BMI) ≥ 35 Kg/m2.

• Those with a history of unilateral oophorectomy or recurrent pregnancy loss, defined as two or more spontaneous abortions.

• Acceptors of donated oocytes or performed either In vitro Maturation (IVM) or blastocyst biopsy for Preimplantation Genetic Diagnosis (PGD) or Preimplantation Genetic Testing for Aneuploidies (PGT-A).

• Those previously diagnosed with congenital (e.g., mediastinal uterus and double uterus) or acquired (e.g., submucosal myoma and adenomyosis) uterine abnormalities.

• Presence of a non-surgically treated hydrosalpinx or endometrial polyp and an ovarian endometriosis cyst requiring surgery, during ovarian stimulation.

• Allergy to or intolerance of the drugs used in the study.

• Combined contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormalities of liver and kidney function, diabetes mellitus (glycosylated haemoglobin ≤7%, fasting blood glucose <10 mmol/L ), hypertension, thyroid disease, symptomatic heart disease, moderate to severe anaemia, history of malignancy or thromboembolism or propensity to thrombosis, severe psychiatric disorder, acute infections of the genitourinary system, sexually transmitted diseases, serious adverse habits such as drug abuse, exposure to teratogenic amounts of radiation, toxins, or drugs (such as prednisone or other hormones, adrenaline, antibiotics, or hypertension, cardiovascular, or antiviral medications) during the active procedure period , and uterine factor infertility or physical illness which prevents the ability to bear a pregnancy.