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

NCT03503006 | Completed

• 1 other identifier: LCYJ-201802
• Study Type: observational
• Target: 2,569
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  Until 28 day after embryo transferred

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

the study population will be selected from patients of Reproductive and Genetic Hospital of CITIC-Xiangya

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Location

Related Publications (1)

• Liu Y, Hocher JG, Ma S, Hu L, Chen H, Zhang X, Gong F, Kramer BK, Lin G, Hocher B. Pre-pregnancy LDL/HDL and total Cholesterol/HDL ratios are strong predictors of gestational diabetes mellitus in women undergoing assisted reproductive technologies. Reprod Biol Endocrinol. 2024 Dec 5;22(1):155. doi: 10.1186/s12958-024-01320-9.

  PMID: 39639281 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: March 21, 2018
• Primary Completion: October 30, 2019
• Study Completion: January 30, 2020
• Last Updated: March 23, 2020

Record last verified: 2018-03

Locations

CN (1)