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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT07296614
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Diminished Ovarian Reserve (DOR)
  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Western Medicine — DRUG
    Letrozole 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 — DRUG
    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.

Study Details

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).

Key Dates

First listed
Dec 22, 2025
Start date
Dec 25, 2025
Status verified
Nov 2025
Primary completion
Jul 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Western medicine group
    Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.
  • Experimental: 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.

Primary Outcome Measure

Cumulative clinical pregnancy rate [ Time Frame: Assessed at study completion, approximately 6 months after enrollment. ]

Central Contacts

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