NCT05459493

Brief Summary

Currently, no drugs have been developed for DOR. We developed the Chinese herbal compound TJAOA101 and has validated its effects in animals. Here, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA101 in therapy of DOR. We aim to provide a solid evidence for TCM in therapy of DOR.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 29, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

June 29, 2022

Last Update Submit

October 18, 2022

Conditions

Diminished Ovarian Reserve

Keywords

Diminished Ovarian ReserveTraditional Chinise Medicine

Outcome Measures

Primary Outcomes (1)

  • recovery rate of ovarian function

    As the definition of DOR is based on AMH or bFSH or AFC, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum AMH increased more than 50%, or serum bFSH decreased more than 50%, or antral follicle count(AFC) increased more than 50% compared with that before treatment，or recover to normal level.

    6 months

Secondary Outcomes (1)

  • recovery rate of menstruation

    6 months

Study Arms (1)

TJAOA101

EXPERIMENTAL

Once enrolled, participants will be administrated TJAOA101 and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period.

Drug: TJAOA101

Interventions

TJAOA101DRUG

Once enrolled, participants will be administrated TJAOA101

TJAOA101

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The age range of patient is 18-40 years old.
  • Women with DOR, and wish to improve ovarian function or menopausal syndrome. The diagnostic criteria for DOR is as follows: If two of the following three tests of ovarian reserve function are met, DOR can be diagnosed: bilateral AFC\<6; AMH \< 1.1 ng/ml; 10 mIU/ml \<bFSH\<25 mIU/ml.
  • Sign the informed consent form.

You may not qualify if:

  • Patient is known to be allergic or unsuitable for the Chinese herbal compound.
  • Women who are pregnant and lactating.
  • Patients had been menopause for more than 1 year.
  • Abnormal uterine bleeding, except ovulation disorders.
  • Women is taking hormone drugs and has stopped taking them within 3 months;
  • Women with endometriosis, myadenosis, submucosal fibroids or the size of non-submucosal fibroids is more than 4 cm.
  • The nature of pelvic mass is unknown.
  • Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
  • Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb\<90g/L) and malignant tumor, and psychiatric patients.
  • Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
  • Unsuitable for the study evaluated by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Study Officials

  • Shixuan Wang, Professor

    Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Shixuan Wang, Professor

CONTACT

+8613995553319shixuanwang@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 15, 2022

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

CN(1)