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

Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility; Diminished Ovarian Reserve (DOR)
• Intervention / Treatment: Drug: Western Medicine; Drug: Placebo; Drug: Traditional Chinese Medicine

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yingying Guo, Doctor; Phone Number: 86+010-69158331; Email: guoyy28@gmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patients aged 22 to 39 years (inclusive).
2. Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH < 1.1 ng/mL; AFC < 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse).
3. Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine
4. Voluntarily participate in this study and provide written informed consent.

Exclusion Criteria:

1. Patients with premature ovarian insufficiency or premature ovarian failure (basal FSH >25 IU/L), organic pathologies such as ovarian tumors, endometrial tuberculosis, intrauterine adhesions, or endometrial injuries, as well as those with congenital adrenal hyperplasia or Cushing's syndrome;
2. Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.
3. Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).
4. DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.).
5. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.
6. Individuals with known allergies to the investigational drug or its components.
7. Use of hormonal medications (e.g., estrogen, contraceptive drugs) within one month prior to enrollment, or use of kidney-tonifying Chinese herbal medicines or proprietary Chinese medicinal products within one month prior to enrollment.
8. Patients currently participating in or planning to participate in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Western medicine group; Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.	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: 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.
Experimental: Integrated traditional Chinese and Western medicine; Take the "Xiehe DOR Kidney-Tonifying Universal Formula" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative clinical pregnancy rate	The rate of intrauterine pregnancy confirmed by transvaginal ultrasound	Assessed at study completion, approximately 6 months after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indicators related to ovarian reserve function	sex hormone levels(AMH, FSH), antral follicle count(AFC)	Baseline, 3-months, 6-months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Shandong University; Guangdong Provincial Hospital of Traditional Chinese Medicine; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhengzhou University; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Xiamen University; Beijing University of Chinese Medicine; First Affiliated Hospital of Heilongjiang Chinese Medicine University; Beijing Obstetrics and Gynecology Hospital; Hunan Provincial Maternal and Child Health Care Hospital; Hunan University of Traditional Chinese Medicine; Dongfang Hospital Beijing University of Chinese Medicine; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; The Third Affiliated Hospital of Beijing University of Chinese Medicine; The Affiliated Hospital of Shandong University of Traditional Chinese Medicine; Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan); Institute of Basic Medical Sciences CAMS; Shenyang Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Infertility; Randomized controlled trial; Diminished ovarian reserve (DOR); Integrated Traditional Chinese and Western Clinical Medicine
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Therapeutics; Complementary Therapies; Medicine, East Asian Traditional; Medicine, Traditional; Medicine, Chinese Traditional
• Other Study ID Numbers: K9220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No