NCT07296614

Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy

Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 22 Years – 39 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diminished Ovarian Reserve (DOR)
• Infertility

Interventions

Type	Name	Description
DRUG	Western Medicine	Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
DRUG	Traditional 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.
DRUG	Placebo	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.

Timeline

• Start date: 2025-12-25
• Primary completion: 2028-07-30
• Completion: 2028-07-30
• First posted: 2025-12-22
• Last updated: 2025-12-22

Locations

1 site across 1 country: China