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A randomized controlled trial for 'tonifying kidney and removing blood stasis' traditional Chinese medicine in the treatment of patients with decreased ovarian reserve after chocolate cyst removal

Phase 1
Conditions
Ovarian dysfunction
Registration Number
ITMCTR1900002379
Lead Sponsor
Department of gynecology, Fangcun Branch of Guangdong Provincial Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

(1) aged 18-39 years;
(2) iatrogenic ovarian reserve function decreased after the operation of ovarian endometriosis (removal of cysts, unilateral adnexectomy, and intervention);
(3) decreased ovarian reserve function: AMH was lower than the lower limit of the reference range of this age group (referring to the AMH test of patients, the standard of our hospital was: 20-24 years old: 1.52ng/ml, 25-29 years old: 1.2ng/ml, 30-34 years old: 0.711ng/ml, 36-39 years old: 0.405ng/ml);The follicular count of basal sinus was less than 5 at the 2nd to 5th day of menstruation. The basic FSH value on the 2-5 days of menstruation was greater than 10IU/L. The basic E2 value on the 2-5 days of menstruation was greater than 80pg/ml. Any one of the above four indicators can be included;
(4) normal menstruation before operation.Show menstruation is normal or abnormal, but menstruation closes time 3 months less than;
(5) TCM syndrome differentiation belongs to kidney deficiency and blood stasis;
(6) informed consent.

Exclusion Criteria

(1) use hormones at present or within 3 months before enrollment;
(2) irregular menstruation before operation. Menstrual arrested over 3 months;
(3) congenital gonadal hypoplasia; With a history of autoimmune diseases, pelvic infectious diseases, mumps, etc.;
(4) polycystic ovary syndrome, hyperprolactinemia, dysfunctional uterine bleeding, hypogonadotropin, hypothyroidism and other endocrine diseases (disorders);
(5) surgery history for other adnexas;
(6) With a history of using reproductive toxic drugs, chemotherapy drugs and radiotherapy;
(7) suspected genetic factors of ovarian decline;
(8) pregnant or lactating women;
(9) people with bad living habits (such as frequent smoking, excessive drinking, frequent hair coloring, excessive weight loss, etc.);
(10) patients with severe mental illness;
(11) participated in other clinical trials in the past 3 months;
(12) bilateral adnexectomy due to Chocolate cyst; Chocolate cyst recurrence.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
menstrual cycle;Ovulation;Anti mullerian canal hor;Assessment of menstrual volume;
Secondary Outcome Measures
NameTimeMethod
uteinizing Hormone;Endometriosis quality of life scale (ehp-5);Sinus follicular count;oestrogen;Follicle-Stimulating Hormone;rate of pregnancy;
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