Vitamin D Deficiency Among Women With Unexplained Infertility (Infertility)

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: NCT03396237
Recruitment Status : Not yet recruiting
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital

Brief Summary:
Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not?

Condition or disease
Case Control Study

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
Estimated Enrollment : 108 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Vitamin D Deficiency Among Women With Unexplained Infertility
Estimated Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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

Primary Outcome Measures :
  1. Vitamin D level [ Time Frame: 6 months ]
    Serum vitamin D level in women with unexplained infertility and fertile pregnant women.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mid aged women with unexplained infertility group and another fertile group to compare vitamin D inbetween them

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.

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): NCT03396237

Contact: Sobhy R Mohammed, MBBCH 01003815460 ext 002
Contact: Ahmed M Bahaa eldin, MD 01111700556 ext 002

Sponsors and Collaborators
Ain Shams Maternity Hospital
Study Director: Hassan T Khairy, Professor Hassan tawfek office

Responsible Party: Ahmed Mohamed Bahaa Eldin Ahmed, Clincal professor, Ain Shams Maternity Hospital Identifier: NCT03396237     History of Changes
Other Study ID Numbers: Vitamin D and Infertility
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

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

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