Vitamin D Deficiency Among Women With Unexplained Infertility (Infertility)

January 5, 2018 updated by: Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not?

Study Overview

Status

Unknown

Conditions

Detailed Description

The study will be done on women with unexplained infertility as a case group and fertile pregnant women as control group to detect if there's a difference in serum level of vitamin D between two groups which will help in the future for curing unexplained infertility women.

Study Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Mid aged women with unexplained infertility group and another fertile group to compare vitamin D inbetween them

Description

Inclusion Criteria:

  • women with unexplained infertility.
  • pregnant fertile women as control group.

Exclusion Criteria:

  • • Endocrinopathies such as (diabetes mellitus, thyroid disorders, parathyroid disorders and hyperprolactinemia), cardiovascular related diseases, severe infection, malignancies and concomitant diseases contribute to Vit D deficiency.

    • Women with ovulatory factor like PCOS,anovulation and poor ovarian reserve are excluded.
    • Women with endometriosis are excluded.
    • Women with autoimmune diseases like antiphospholipid antibodies or lupus erythematosus are excluded.
    • Documented uterine anomalies, tubal factor, cervical factor and other local causes of infertility.
    • Male factor of infertility is excluded.
    • Bone and metabolic disease, liver diseases and kidney related diseases.

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
Group A
Case group contain cases of unexplained infertility women
Group B
Control group contain fertile pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D level
Time Frame: 6 months
Serum vitamin D level in women with unexplained infertility and fertile pregnant women.
6 months

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Study Director: Hassan T Khairy, Professor, Hassan tawfek office

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 (Anticipated)

January 10, 2018

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D and Infertility

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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