Clinical study on the efficacy and safety of Bushen Culuan fang in treating anovulatory infertility caused by hyperprolactinemia

Early Phase 1

• Conditions: Hyperprolactinemia

• Registration Number: ITMCTR2024000017
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

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

Inclusion Criteria

(1) Between 20 and 40 years old;
(2) Meet the diagnostic criteria for infertility;
(3) Meet the diagnostic criteria of hyperprolactinemia;
(4) Meet the diagnostic criteria of TCM kidney deficiency and blood stasis syndrome;
(5) Voluntarily sign the informed consent.

Exclusion Criteria

(1) ovulation disorders or infertility caused by congenital physiological defects or malformations:
(2) infertility caused by genetic factors;
(3) Infertility caused by fallopian tube factors, or immune factors, or uterine fibroids, or myoadenosis, or endometriosis, or uterine dysplasia, confirmed by examination;
(4) abnormal reproductive function of the spouse;
(5) serious abnormalities of cardiovascular, liver, kidney or hematopoietic system;
(6) Psychiatric diseases and other diseases that cause abnormal lactation;
(7) Allergy to known investigational drug ingredients.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Ovulation rate;

Secondary Outcome Measures

Name	Time	Method
Sex Hormone levels(FSH\ LH\ E2\P\T\PRL);Ovulatory B-ultrasound;Anti-mullerian hormone(AMH);Blood clotting (FIB, APTT, TT, PT);integral of TCM kidney deficiency and blood stasis syndrome;INHB;Early follicular stage B-ultrasound;Basal body temperature normalization rate;