NCT07296614

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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
26mo left

Started Dec 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Dec 2025Jul 2028

First Submitted

Initial submission to the registry

November 28, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2028

Last Updated

December 22, 2025

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

November 28, 2025

Last Update Submit

December 18, 2025

Conditions

InfertilityDiminished Ovarian Reserve (DOR)

Keywords

Diminished ovarian reserve (DOR)InfertilityIntegrated Traditional Chinese and Western Clinical MedicineRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Cumulative clinical pregnancy rate

    The rate of intrauterine pregnancy confirmed by transvaginal ultrasound

    Assessed at study completion, approximately 6 months after enrollment.

Secondary Outcomes (1)

  • Indicators related to ovarian reserve function

    Baseline, 3-months, 6-months

Study Arms (2)

Western medicine group

PLACEBO COMPARATOR

Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.

Drug: Western MedicineDrug: Placebo

Integrated traditional Chinese and Western medicine

EXPERIMENTAL

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 MedicineDrug: Traditional Chinese Medicine

Interventions

Western MedicineDRUG

Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).

Integrated traditional Chinese and Western medicineWestern medicine group
Traditional Chinese MedicineDRUG

"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.

Integrated traditional Chinese and Western medicine
PlaceboDRUG

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.

Western medicine group

Eligibility Criteria

Age22 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Infertility

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Central Study Contacts

Yingying Guo, Doctor

CONTACT

86+010-69158331guoyy28@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 22, 2025

Study Start

December 25, 2025

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

July 30, 2028

Last Updated

December 22, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)