Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Cumulative clinical pregnancy rate
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.).
- •Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.
- •Individuals with known allergies to the investigational drug or its components.
- •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.
- •Patients currently participating in or planning to participate in other clinical trials.
Arms & Interventions
Western medicine group
Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.
Intervention: Western Medicine (Drug)
Western medicine group
Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.
Intervention: Placebo (Drug)
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.
Intervention: Western Medicine (Drug)
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.
Intervention: Traditional Chinese Medicine (Drug)
Outcomes
Primary Outcomes
Cumulative clinical pregnancy rate
Time Frame: Assessed at study completion, approximately 6 months after enrollment.
The rate of intrauterine pregnancy confirmed by transvaginal ultrasound
Secondary Outcomes
- Indicators related to ovarian reserve function(Baseline, 3-months, 6-months)