NCT07737847

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Oct 2026

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 20, 2026

Last Update Submit

July 28, 2026

Conditions

Diminished Ovarian Reserve (DOR)

Keywords

shoutai pilloocyteDiminished Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

  • Number of MII oocyte

    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.

    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.

Secondary Outcomes (6)

  • FSH

    Basline， and after 3 months of treatment

  • AMH

    Basline， and after 3 months of treatment

  • 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.

  • AFC

    Basline， and after 3 months of treatment

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Shoutai Pill

EXPERIMENTAL

The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

Drug: Shoutai Pill

Control group

PLACEBO COMPARATOR

The experimental group took Placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months.

Drug: Placebo

Interventions

Shoutai PillDRUG

The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

Shoutai Pill
PlaceboDRUG

The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

Control group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ② no use of estrogen-containing medications within the past 1 month
  • ③ patients scheduled to undergo IVF-ET
  • ④ provision of signed informed consent, voluntary participation, and good compliance.

You may not qualify if:

  • ② uterine conditions including untreated submucous myomas, intramural myomas \>4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies
  • ③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons
  • ④ body mass index (BMI) ≥28 kg/m²
  • ⑤ history of prior pelvic radiotherapy or cytotoxic chemotherapy
  • ⑥ significant systemic diseases, such as uncontrolled hypertension, diabetes mellitus, thyroid dysfunction, hepatic or renal insufficiency, cardiac disorders, or autoimmune diseases
  • ⑦ use of medications that may interfere with this study within the past 1 month, including but not limited to estrogens, hepatic enzyme modulators, and agents that may affect the endocrine system (hormonal drugs)
  • ⑧ known allergy to any components of the study medication
  • and ⑨ participation in another drug trial within the past 3 months. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100732, China

Location

Central Study Contacts

xue wang, MD

CONTACT

+86 010 69158335wangxue2098@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 30, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

only IPD used in the results publication

Shared Documents
STUDY PROTOCOL
Time Frame
after publication

Locations

CN(1)