|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
18 April 2017 |
|
Main ID: |
ChiCTR-ICR-15006657 |
|
Date of registration:
|
2015-06-21 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Multicenter double-blind double-simulated randomized controlled trial of activating renal blood circulation and ovarian stimulation infusion in treating ovarian dysfunction (ovulation failure infertility)
|
|
Scientific title:
|
the reactive mechanism study of improving ovarian of gonadotropins in activating renal blood circulation and ovarian stimulation scheme in treating ovarian dysfunction (ovulation failure infertility) |
|
Date of first enrolment:
|
2012-01-01 |
|
Target sample size:
|
the treating group:177;the control group:172; |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=11262 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
New Treatment Measure Clinical Study
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Li Min
|
|
Address:
|
16 Nanxiao Street, Inner Dongzhimen, Dongcheng District, Beijing
100700
|
|
Telephone:
|
+86 18813188612 |
|
Email:
|
ifrom2013@163.com |
|
Affiliation:
|
China Academy of traditional Chinese Medicine |
|
|
Name:
|
Ma Kun
|
|
Address:
|
16 Nanxiao Street, Inner Dongzhimen, Dongcheng District, Beijing
100700
|
|
Telephone:
|
+86 13910218105 |
|
Email:
|
makun12348@sina.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. primary and secondary infertility participants who were under 35 years old not contraceptive 1 year or over 35 years old not contraceptive 6 month;
2. Conform to the diagnostic criterias of dysfunctional uterine bleeding, polycystic ovary syndrom, hyperprolactinemia, Luf follicle unruptured syndrome, luteal phase deficiency and diminished ovarian reserve;
3. Syndrome differentiation of traditional Chinese medicine is kidney deficiency and blood stasis;
4. During the treatment, couples live together and have normal sex life;
5. Each participant freely signs the informed consent.
Exclusion criteria: 1. Infertility caused by congenital brith defect or deformity;
2. Infertility caused by genetic factors;
3. Infertility caused by oviduct, immune factors, endometriosis, uterine muscle adenopathy, uterine fibroids, uterine dysplasia;
4. male reproductive dysfunction;
5. with cardiovascular, liver, kidney and hematopoietic system illness or psychiatric patients;
6. Drug allergy to investigational drugs.
Age minimum:
Age maximum:
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
ovarian dysfunction (ovulation failure infertility)
|
|
Intervention(s)
|
|
the treating group:activating renal blood circulation and ovarian stimulation infusion;the control group:clomiphene;
|
|
Primary Outcome(s)
|
|
Ovulation rate;pregnancy rate;TCM symptom score;endometrium;diameter of dominant follicle;Sex hormones;
|
|
Secondary Outcome(s)
|
|
blood routine examination;urinary routine examination;stool routine test;blood coagulation test;electrocardiography;hepatic and renal function test;
|
|
Source(s) of Monetary Support
|
|
Medical science and technology development fund in the capital
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|