NCT03973528

Brief Summary

This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the treatment of elderly infertile women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

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 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

June 2, 2019

Last Update Submit

March 8, 2022

Conditions

Infertility, Female

Keywords

anti-Mullerian hormone (AMH)Traditional Chinese Medicine(TCM)Infertility

Outcome Measures

Primary Outcomes (2)

  • serum anti-Mullerian hormone (AMH) index

    The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by examining serum anti-Mullerian hormone (AMH) index

    three months

  • total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).

    The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by the total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).

    three months

Study Arms (2)

traditional Chinese medicine

EXPERIMENTAL

The experimental group use traditional Chinese medicine

Drug: traditional Chinese medicine: tonifying kidney Wan

non- traditional Chinese medicine

NO INTERVENTION

The no intervention group no use traditional Chinese medicine.

Interventions

traditional Chinese medicine: tonifying kidney WanDRUG

traditional Chinese medicine : tonifying kidney Wan

Also known as: tonifying kidney Wan I: Zuo Gui Wan, tonifying kidney Wan II :Guilu Erxian
traditional Chinese medicine

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEvaluation of Traditional Chinese medicine treatment of infertile women older than 35 years of efficacy.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A. Women aged 35-45, married, without contraception, after 12 months of normal sexual life, did not take any contraceptive measures, and did not successfully conceive women.
  • B. Blood tests for serum anti-Mullerian hormone ( AMH) less than 1.2, female hormones FSH, LH, E2 blood test is normal.
  • C. Women who are not planning for IUI or IVF in the next three months. D. Menstrual cycle rules 21-35 days. E. Willing to sign a written consent form.

You may not qualify if:

  • A. Women with contraceptive. B. Vegetarians or have been taking Traditional Chinese medicine allergies. C. The following diseases have occurred in the past six months: cancer, high blood pressure, diabetes, heart disease, stroke, myocardial infarction, hyperthyroidism or hypothyroidism, chronic hepatitis, gastric ulcer, stomach bleeding, chronic constipation or diarrhea, major trauma and surgery, severe uterine and pelvic infections.
  • D. Because of the need for disease, it is currently necessary to take western medicine for more than three months.
  • E. Women with abnormal liver function (GOT, GPT greater than 2 times the upper limit of normal).
  • F. Women with abnormal renal function (serum creatinine \> 1.5 mg/dl). G. Poor compliance with medication. H. In the past month, take a Traditional Chinese medicine to treat infertility. I. Take DHEA for the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33302, Taiwan

Location

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Tsang-Tang Hsieh, MD

    Chang Gung MH IRB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 4, 2019

Study Start

July 8, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

TW(1)