Overview

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

Status:
Unknown status
Trial end date:
2020-08-31
Target enrollment:
0
Participant gender:
Female
Summary
This study is to evaluate the effectiveness and safety of Bushen Culuan Decoction in the treatment of anovulatory infertility, including anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency, through a randomised, double-blinded, double-dummy, parallel positive controlled, adaptive multicenter clinical trial.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators:
Beijing Fengtai Hospital of Integrated Traditional and Western Medicine
Beijing First Hospital of integrated Chinese and Western Medicine
Beijing Hospital of Traditional Chinese Medicine
Beijing Obstetrics and Gynecology Hospital
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Dongzhimen Hospital, Beijing
Treatments:
Citric Acid
Clomiphene
Enclomiphene
Sodium Citrate
Zuclomiphene
Criteria
Inclusion Criteria:

1. Aged 21~40 years old;

2. Diagnosed with infertility;

3. Diagnosed with one of below diseases: anovulatory abnormal uterine bleeding,
polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle
syndrome, corpus luteum insufficiency and ovarian insufficiency,

4. Diagnosed with TCM syndrome of kidney deficiency and blood stasis syndrome;

5. Patients who has normal sexual intercourse during treatment;

6. Voluntary to sign the informed consent.

Exclusion Criteria:

1. Infertility due to congenital physiological defect or malformation;

2. Infertility due to hereditary factors；

3. Infertility due to oviduct defect, immune factors, uterine fibroid, adenomyosis,
endometriosis or hypoplasia of uterus；

4. Spouse has reproductive defects；

5. Severe abnormity of cardiovascular system, liver function, kidney function or
hemopoietic system；

6. Allergy to experimental drugs