Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy

Summary

This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen ("Xiehe DOR Bushen Tongzhi Formula" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation monitoring and timed intercourse) in improving the natural cumulative clinical pregnancy rate in infertile patients with kidney deficiency-type diminished ovarian reserve (DOR).

Conditions

• Diminished Ovarian Reserve (DOR)
• Infertility

Interventions

DRUG

Western Medicine

Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).

DRUG

Traditional Chinese Medicine

"Xiehe DOR Kidney-Tonifying Universal Formula" is a traditional Chinese medicine (TCM) granule formulation prepared in-hospital. It is taken by dissolving one sachet in hot water, three times daily.

DRUG

Placebo

The appearance and packaging of the placebo are exactly the same as those of "Xiehe DOR Kidney-Tonifying Universal Formula". It is also taken by dissolving one sachet in hot water, three times daily.

Sponsors & Collaborators

• Dongfang Hospital Beijing University of Chinese Medicine

  collaborator OTHER

• Beijing University of Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Shandong University

  collaborator OTHER

• Xiamen University

  collaborator OTHER

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• The Third Affiliated Hospital of Beijing University of Chinese Medicine

  collaborator OTHER

• Hunan Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Institute of Basic Medical Sciences CAMS

  collaborator UNKNOWN

• First Affiliated Hospital of Heilongjiang Chinese Medicine University

  collaborator OTHER

• Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Shenyang Women's and Children's Hospital

  collaborator UNKNOWN

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

39 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-25

Primary Completion

2028-07-30

Completion

2028-07-30

Countries

• China

Study Locations