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Primary Efficacy Evaluation of Traditional Chinese Medicine in Treating Older Infertile Women

Primary Purpose

Infertility, Female

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
traditional Chinese medicine: tonifying kidney Wan
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring anti-Mullerian hormone (AMH), Traditional Chinese Medicine(TCM), Infertility

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

traditional Chinese medicine

non- traditional Chinese medicine

Arm Description

The experimental group use traditional Chinese medicine

The no intervention group no use traditional Chinese medicine.

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Full Information

First Posted
June 2, 2019
Last Updated
March 8, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03973528
Brief Title
Primary Efficacy Evaluation of Traditional Chinese Medicine in Treating Older Infertile Women
Official Title
A Preliminary Evaluation of the Efficacy of Traditional Chinese Medicine in Treating Elderly Women With Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the treatment of elderly infertile women.
Detailed Description
Research design: initial acceptance of 60 people, 30 in the no intervention group and 30 in the experimental group. The no intervention group no use Traditional Chinese medicine. The experimental group use Traditional Chinese medicine. Affect natural pregnancy and IVF success factors, the quality of ovarian function plays a very important role. Currently used to predict ovarian follicle inventory indicators, including: age, the total number of small sized ovarian follicles, the first three days of menstrual follicle-stimulating hormone, Anti-Mullerian hormone, inhibin-B. Research Analysis Chang Gung Memorial Hospital infertility patients using traditional Chinese medicine, more than 40-year-old infertility patients, the most commonly used compound is Zuo Gui Wan. Chinese medicine believes that elderly women with infertility ovulation poor, the main pathogenesis of kidney deficiency. The proportion of domestic infertility patients has increased year by year. Traditional Chinese medicine had become popular and acceptable, but the substantial evidence and treatment consensus of infertility are scanty. Due to the outbreak of the new crown pneumonia epidemic, which made it difficult to accept the case. Only 17 subjects in the experimental group completed the test. The average age of the subjects was 40.11 ±3.09 years old, and 9 of them were over 40 years old. The AMH before the test was all below 1.2. After three months of treatment with traditional Chinese medicine, 16 subjects had an increase in the number of small sized ovarian follicles. The average total number of small ovarian follicles before the test was 3.06±0.90, and the average increased to 4.53±1.46 after treatment. (P<0.05), which was statistically significant. Eleven subjects showed a decrease in follicle-stimulating hormone on the third day of menstruation after treatment, 9 subjects showed an increase in anti-Mullerian hormone (AMH) value after treatment, and 3 subjects had anti-Mullerian hormone (AMH) values higher than 1.2 after treatment, but they did not reach statistical significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
anti-Mullerian hormone (AMH), Traditional Chinese Medicine(TCM), Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
traditional Chinese medicine
Arm Type
Experimental
Arm Description
The experimental group use traditional Chinese medicine
Arm Title
non- traditional Chinese medicine
Arm Type
No Intervention
Arm Description
The no intervention group no use traditional Chinese medicine.
Intervention Type
Drug
Intervention Name(s)
traditional Chinese medicine: tonifying kidney Wan
Other Intervention Name(s)
tonifying kidney Wan I: Zuo Gui Wan, tonifying kidney Wan II :Guilu Erxian
Intervention Description
traditional Chinese medicine : tonifying kidney Wan
Primary Outcome Measure Information:
Title
serum anti-Mullerian hormone (AMH) index
Description
The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by examining serum anti-Mullerian hormone (AMH) index
Time Frame
three months
Title
total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).
Description
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).
Time Frame
three months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Evaluation of Traditional Chinese medicine treatment of infertile women older than 35 years of efficacy.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsang-Tang Hsieh, MD
Organizational Affiliation
Chang Gung MH IRB
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33302
Country
Taiwan

12. IPD Sharing Statement

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Primary Efficacy Evaluation of Traditional Chinese Medicine in Treating Older Infertile Women

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