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).
Female patients aged 22 to 39 years (inclusive).
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).
Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine
Voluntarily participate in this study and provide written informed consent.
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;
Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.
Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).
DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.).
Parallel
Western Medicine
DrugLetrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
Traditional Chinese Medicine
Drug"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.
Placebo
DrugThe 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.
Cumulative clinical pregnancy rate
The rate of intrauterine pregnancy confirmed by transvaginal ultrasound
Indicators related to ovarian reserve function
sex hormone levels(AMH, FSH), antral follicle count(AFC)
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Dongfang Hospital Beijing University of Chinese Medicine
Collaborator
Beijing University of Chinese Medicine
Collaborator
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Hunan University of Traditional Chinese Medicine
Collaborator
Shandong University
Collaborator
Xiamen University
Collaborator
Beijing Obstetrics and Gynecology Hospital
Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborator
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Collaborator
Hunan Provincial Maternal and Child Health Care Hospital
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
Institute of Basic Medical Sciences CAMS
Collaborator
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Collaborator
Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Shenyang Women's and Children's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
