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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03503006
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

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.

Condition or disease
Infertility, Female

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: Until 28 day after embryo transferred ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the study population will be selected from patients of Reproductive and Genetic Hospital of CITIC-Xiangya

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03503006

China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA Recruiting
Changsha, Hunan, China, 410008
Contact: Sufen Cai, doctor    0731-82355100   
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya

Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya Identifier: NCT03503006     History of Changes
Other Study ID Numbers: LCYJ-201802
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents