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The Effect of Vitamin D on in Vitro Fertilization Outcome

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ClinicalTrials.gov Identifier: NCT02361827
Recruitment Status : Unknown
Verified February 2015 by Yingpu Sun, The First Affiliated Hospital of Zhengzhou University.
Recruitment status was:  Recruiting
First Posted : February 12, 2015
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Yingpu Sun, The First Affiliated Hospital of Zhengzhou University

Brief Summary:
To date, several studies have been done to explore the relationship between Vitamin D level and IVF outcome; however, the results are controversial. Sample sizes in these studies mentioned above were relatively small. In addition, there are no prospective cohort studies in this field. Thus, here the investigators carry this prospective observational cohort study to demonstrate the relationship between vitamin D level and IVF outcome.

Condition or disease Intervention/treatment
Ongoing Pregnancy Rate Vitamin D in Vitro Fertilization Procedure: Embryo transfer

Detailed Description:

Vitamin D level is measured on the day of HCG administration. According to Vitamin D level, patients are divided into 3 groups: A, Deficient, <20 ng/mL; B, Insufficient, 20-29.9 ng/mL; C, Replete, >30 ng/mL.

Ongoing pregnancy rate are compared among these three groups after controlling age, number of embryos transferred, ect.


Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Vitamin D on in Vitro Fertilization Outcome, a Prospective Observational Study
Study Start Date : January 2015
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
A, Vitamin D deficient
Vitamin D level on the day of HCG administraion < 20 ng/mL Embryo transfer after oocyte retrieval.
Procedure: Embryo transfer
For patients in each group, they will have embryo transferred 3 or 5 days after oocyte retrieval.

B, Vitamin D insufficient
Vitamin D level on the day of HCG administraion 20-29.9 ng/mL Embryo transfer after oocyte retrieval.
Procedure: Embryo transfer
For patients in each group, they will have embryo transferred 3 or 5 days after oocyte retrieval.

C, Vitamin D replete
Vitamin D level on the day of HCG administraion > 30 ng/mL Embryo transfer after oocyte retrieval.
Procedure: Embryo transfer
For patients in each group, they will have embryo transferred 3 or 5 days after oocyte retrieval.




Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 12 weeks after embryo transfer ]
    12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus


Secondary Outcome Measures :
  1. Ectopic pregnancy rate [ Time Frame: 35 days after embryo transfer ]
    Ectopic pregnancy is defined as serum HCG positive, yet with no gestational sac present inside uterine cavity


Biospecimen Retention:   Samples With DNA
Serum


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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients whose IVF cycles were cancelled due to ovarian hyperstimulation syndrome were also excluded);.
Criteria

Inclusion Criteria:

  1. age between 21-40 years old
  2. basal FSH hormone level less than 10 mIU/mL
  3. the first cycle of IVF treatment with standard long protocol
  4. both ovarian present and normal uterus.

Exclusion Criteria:

  1. PGD cycles
  2. Gametes donation cycles
  3. Anyone that does not meet the inclusion criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02361827


Contacts
Contact: Yingpu Ms Sun, MD,PhD 86-13503841888 syp2008@vip.sina.com

Locations
China, Henan
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Yingpu Ms Sun, M.D,PhD    86-13803841888    syp2008@vip.sina.com   
Contact: Zhiqin Mr Bu, MD    86-15981978863    rmczzu@126.com   
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
Investigators
Study Chair: Yingpu Ms Sun, MD, PhD Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Publications:
Responsible Party: Yingpu Sun, Director of Reproductive Medicine Center, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT02361827     History of Changes
Other Study ID Numbers: RMCZZU-Vitamin D
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Yingpu Sun, The First Affiliated Hospital of Zhengzhou University:
Vitamin D
IVF outcome

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents