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

NCT ID: NCT03973528

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

traditional Chinese medicine

The experimental group use traditional Chinese medicine

Group Type EXPERIMENTAL

traditional Chinese medicine: tonifying kidney Wan

Intervention Type DRUG

traditional Chinese medicine : tonifying kidney Wan

non- traditional Chinese medicine

The no intervention group no use traditional Chinese medicine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

traditional Chinese medicine: tonifying kidney Wan

traditional Chinese medicine : tonifying kidney Wan

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tonifying kidney Wan I: Zuo Gui Wan tonifying kidney Wan II :Guilu Erxian

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tsang-Tang Hsieh, MD

Role: STUDY_CHAIR

Chang Gung MH IRB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Chang Gung MH

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201702097A3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.