A randomized controlled clinical study of acupuncture combined with medicine in the treatment of ovarian hypofunctio

Phase 1

• Conditions: Ovarian dysfunction

• Registration Number: ITMCTR2000003595
• Lead Sponsor: Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

The DOR diagnostic criteria of western medicine and the diagnostic criteria of spleen and kidney deficiency syndrome of Traditional Chinese medicine, the patients who had regular menstruation in the past, had not used estrogen, Traditional Chinese medicine and acupuncture treatment in the recent 3 months, volunteered to participate in this study and insisted on treatment, and actively cooperated with the follow-up visits, were all included in this study after signing the informed consent.

Exclusion Criteria

1. Aged < 18 years old or > 40 years;
2. Bilateral or unilateral ovariectomy or chemoradiotherapy caused DOR;
3. Chromosomal karyotype abnormality;
4. Congenital or acquired reproductive organ organic diseases and caused menstrual disorders;
5. For patients without menstrual symptoms, infertility caused by male factors, tubal factors, organic diseases of the reproductive organs and other factors other than THE DOR should be excluded;
6. Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems, mental diseases and breast tumors;
7. Take estrogen, traditional Chinese medicine and acupuncture treatment history or history of amenorrhea within 3 months;
8. Is allergic to a variety of drugs or known to be allergic to the composition of the drug;
9. Pet-name failure to take prescribed drugs or to follow up regularly, unable to determine the efficacy or incomplete data affecting the efficacy.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AMH;Pregnancy rate, abortion rate;

Secondary Outcome Measures

Name	Time	Method
T, FSH, LH, E2, PRL;AFC and ovarian volume;TCM symptom and sign score;