Serum Vitamin D Level and Its Association With Ovarian Reserve and IVF Outcome

December 11, 2014 updated by: monika chawla, Fakih IVF Fertility Center

Serum Vitamin D Level in Subfertile Women and Its Association With Ovarian Reserve and IVF Outcome.

Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .

The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .

The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
    • Abu Dhabi
      • Abudhabi, Abu Dhabi, United Arab Emirates, 31453
        • Recruiting
        • Fakihivf Fertiity Center
        • Contact:
          • MONIKA CHAWLA, MD
          • Phone Number: 97124444107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing IVF between 20-42 years of age

Description

Inclusion Criteria:

  • Subfertile women,
  • Indication for IVF,
  • 20-42 yrs of age.

Exclusion Criteria:

  • Women on therapeutic supplementation for Vitamin D Deficiency,
  • Recurrent high order implantation failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal vitamin D levels group
MORE THAN 20 NG/ML VITAMIN D LEVELS
Other: monitor reproductive outcome
Deficient Vitamin D GROUP
LESS THAN 20 NG/ML LEVELS
Other: monitor reproductive outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 14 days post oocyte retrieval
14 days post oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Time Frame
AMH (antimullerian hormone) Levels
Time Frame: day 2-3 of the index cycle
day 2-3 of the index cycle
AFC (antral follicle count)
Time Frame: DAY 2-3 OF INDEX CYCLE
DAY 2-3 OF INDEX CYCLE
Number of oocytes retreived
Time Frame: Two weeks from the last menstrual period
Two weeks from the last menstrual period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakih IVF Fertility Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VitD Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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