Status:
COMPLETED
Vitamin D and Pregnancy Outcome in PCOS Patients
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Conditions:
Polycystic Ovary Syndrome
in Vitro Fertilization
Eligibility:
FEMALE
20-42 years
Phase:
NA
Brief Summary
This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS. Women with P...
Detailed Description
Polycystic ovary syndrome (PCOS) is one of the leading causes of female infertility, affecting around 5% of women with a child-bearing age in China. Vitamin D insufficiency is common in women with PCO...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Women aged 20 to 42 years old;
- Diagnosed with PCOS (Rotterdam Criteria);
- Scheduled for IVF;
- Written informed consent.
- Exclusion criteria
- Women who had three or more failed IVF cycles;
- Women scheduled for preimplantation genetic testing;
- Known Vitamin D allergy;
- Women with a history of chronic absorption syndrome or bile dysplasia, or parathyroid dysfunction, or kidney stones, or blood Calcium ion concentration greater than 2.6mmol/L (normal value 2.25 - 2.75mmol/L (9 to 11mg/dl), or hyperphosphataemia (1.61mmol/L), or metabolic-related bone disease, or chronic diseases that may cause bone abnormalities (liver and kidney insufficiency);
- Women receiving treatments for tuberculosis, convulsions, and epilepsy because medications treating these diseases may affect the metabolism of vitamin D.
- Women undergoing an IVF treatment with donor oocytes.
Exclusion
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
876 Patients enrolled
Trial Details
Trial ID
NCT04082650
Start Date
October 15 2020
End Date
January 27 2025
Last Update
January 29 2025
Active Locations (2)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China
2
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China