Vitamin D Deficiency Among Women With Unexplained Inferti... | NCT03396237

Studies
Vitamin D Deficiency Among Women With Unexplained Infertility

NCT03396237

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Jan 10, 2018Actual

Enrollment

108Estimated

Phase

Not provided

Conditions

Case Control Study

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2018Estimated

Primary Completion Date

Jun 1, 2018Estimated

Completion Date

Aug 1, 2018Estimated

First Submitted Date

Jan 5, 2018

First Submission Date that Met QC Criteria

Jan 5, 2018

First Posted Date

Jan 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Case group contain cases of unexplained infertility women
Group B		Control group contain fertile pregnant women

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sobhy R Mohammed, MBBCH	Contact	01003815460	002	Sobhyrawy@gmail.com
Ahmed M Bahaa eldin, MD	Contact	01111700556	002	abahaa0503@yahoo.com

Overall Officials

Name	Affiliation	Role
Hassan T Khairy, Professor	Hassan tawfek office	Study Director

Locations

Not provided