A Phase 3 interventional study of Western Medicine and Traditional Chinese Medicine in Diminished Ovarian Reserve (DOR) and Infertility, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 22 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Peking Union Medical College Hospital · Phase 3, Interventional, and Treatment
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).
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 320 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Exclusion Criteria:
Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.
Drug: Western Medicine · Drug: Placebo
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 · Drug: Traditional Chinese Medicine
Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
"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.
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.
Cumulative clinical pregnancy rate
The rate of intrauterine pregnancy confirmed by transvaginal ultrasound
Time frame: Assessed at study completion, approximately 6 months after enrollment.
Indicators related to ovarian reserve function
sex hormone levels(AMH, FSH), antral follicle count(AFC)
Time frame: Baseline, 3-months, 6-months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital