Diminished Ovarian Reserve (DOR)
Conditions
Keywords
shoutai pill, oocyte, Diminished Ovarian Reserve
Brief summary
Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.
Interventions
DRUGShoutai Pill
The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
DRUGPlacebo
The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
Sponsors
Peking Union Medical College Hospital
Beijing Municipal Health Commission
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR 2. ② no use of estrogen-containing medications within the past 1 month 3. ③ patients scheduled to undergo IVF-ET 4. ④ provision of signed informed consent, voluntary participation, and good compliance.
Exclusion criteria
1. The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of MII oocyte | After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval. | On the day of oocyte retrieval, the number of mature oocytes was observed under a microscope. Mature oocytes are defined as oocytes containing the first polar body. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FSH | Basline， and after 3 months of treatment | Follicle-Stimulating Hormone |
| AMH | Basline， and after 3 months of treatment | Anti-Müllerian Hormone |
| number of oocytes retrieved | After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval. | Direct visualization under microscopy |
| AFC | Basline， and after 3 months of treatment | antral follicle count |
| blastocyst formation rate | After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Blastocysts form on days 5/6 post-fertilization; thus, the blastocyst formation rate is assessed on Day 6 | Number of blastocysts / (number of cleavage-stage embryos - number of transferred embryos |
| proportion of good-quality embryos | After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Cleavage embryos form on day3 post-fertilization; thus, the rate is assessed on Day 3 | Number of top-quality embryos / number of cleavage-stage embryos |
Countries
China
Contacts
CONTACTxue wang, MD
Outcome results
None listed