Diminished Ovarian Reserve (DOR), Infertility
Conditions
Keywords
Diminished ovarian reserve (DOR), Infertility, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial
Brief 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).
Interventions
DRUGWestern Medicine
Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
DRUGTraditional 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.
DRUGPlacebo
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
Dongfang Hospital Beijing University of Chinese Medicine
Beijing University of Chinese Medicine
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Hunan University of Traditional Chinese Medicine
Shandong University
Xiamen University
Beijing Obstetrics and Gynecology Hospital
Xiyuan Hospital of China Academy of Chinese Medical Sciences
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Hunan Provincial Maternal and Child Health Care Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Institute of Basic Medical Sciences CAMS
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)
The First Affiliated Hospital of Zhengzhou University
Shenyang Women's and Children's Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative clinical pregnancy rate | Assessed at study completion, approximately 6 months after enrollment. | The rate of intrauterine pregnancy confirmed by transvaginal ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Indicators related to ovarian reserve function | Baseline, 3-months, 6-months | sex hormone levels(AMH, FSH), antral follicle count(AFC) |
Countries
China
Contacts
Primary ContactYingying Guo, Doctor
Outcome results
None listed