Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer

Infertility, Female Clinical Trial

Official title:

Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503006
• Other study ID #: LCYJ-201802
• Status: Completed
• Start date: March 21, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2018
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

At present, there is no agreement on the effect of vitamin D level in serum and follicular fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology. This project intends to make a prospective cohort study with large sample, based on a complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET pregnancy outcome. This study is also the first to study the relationship between maternal vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2569
• Est. completion date: January 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• female with only fallopian tube factor or male factor infertility,first IVF/ICSI cycle,18 years old=age=35 years old,take a long protocol or super-long protocol,18=BMI=25, menstrual regularity(periodic change < 7 days)

Exclusion Criteria:

• Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus =1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma( hysteromyoma=2.0 cm, and/or Uterine fibroids located within the endometrium=1cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate		Until 28 day after embryo transferred