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Main
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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. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-15006369 |
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Date of registration:
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2015-05-08 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The improvement of endometrial receptivity in PCOS patients by Vitamin D3: a prospective randomized controlled clinical trial
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Scientific title:
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The improvement of endometrial receptivity in PCOS patients by Vitamin D3: a prospective randomized controlled clinical trial |
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Date of first enrolment:
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2016-01-01 |
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Target sample size:
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Obesity-Placebo:105;Obesity-Vitamin D3:105;Non-obesity-Placebo:105;Non-obesity-Vitamin D3:105; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10938 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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I (Phase I study)
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Countries of recruitment
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China
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Contacts
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Name:
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Liang Wu
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Address:
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Center for Reproductive Medicine, First Affilited Hospital of Zhengzhou Univercity, 1 Jianshe load, Zhengzhou, Henan, China
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Telephone:
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+86 13203813873 |
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Email:
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rbny@163.com |
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Affiliation:
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Name:
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Liang Wu
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Address:
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Center for Reproductive Medicine, First Affilited Hospital of Zhengzhou Univercity, 1 Jianshe load, Zhengzhou, Henan, China
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Telephone:
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+86 13203813873 |
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Email:
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rbny@163.com |
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Affiliation:
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Center for Reproductive Medicine, First Affilited Hospital of Zhengzhou Univercity |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Vitamin deficiency (< 20 ng/mL);
2. Anovulatory patients with PCOS;
3. All patients were excluded from other endocrine disorders, and has not used hormone drugs for almost 3 months;
4. Age: 25-39.
Exclusion criteria: 1. Malformation of uterus: such as uterus unicornis, uterus bicornis, untreated uterus septus, etc.;
2. History of endometrial diseases: such as intrauterine adhesion, uterine cavity tuberculosis, severe dysplasia of endometrium, etc.;
3. Multiple myomata or endometrioma which causes uterus oppression;
4. Multiple and recurrent endometrial polyps;
5. Pelvic tuberculosis, endometriosis.
Age minimum:
25
Age maximum:
39
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Female Infertility
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Intervention(s)
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Obesity-Placebo:Placebo for three months;Obesity-Vitamin D3:Vitamin D3 for three months;Non-obesity-Placebo:Placebo for three months;Non-obesity-Vitamin D3:Vitamin D3 for three months;
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Primary Outcome(s)
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Clinical pregnancy rate;
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Secondary Outcome(s)
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Embryo implantation rate;Live birth rate;Miscarriage rate;Preterm birth rate;
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Source(s) of Monetary Support
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MerckSerono China Research Fund for Fertility Experts
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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