Vitamin D Supplementation in Vitamin Deficient Women Unde... | NCT03209856

Studies
Vitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?

NCT03209856

Sponsor

Cairo University

Status

Completed

Last Update Posted

Oct 6, 2021Actual

Enrollment

200Actual

Phase

Phase 4

Conditions

Infertility

Interventions

Vitamin D

Countries

Egypt

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2017Actual

Primary Completion Date

Mar 20, 2021Actual

Completion Date

Apr 20, 2021Actual

First Submitted Date

Jul 4, 2017

First Submission Date that Met QC Criteria

Jul 4, 2017

First Posted Date

Jul 6, 2017Actual

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

Oct 5, 2021

Last Update Posted Date

Oct 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the success of IVF cycles.

Detailed Description

The study participants are vitamin D deficient females undergoing (intra-cytoplasmic sperm injection (ICSI) trial in the age of 20 to 35 years. Serum vitamin D will be assessed. Accordingly, if they are deficient in vitamin D, they will be eligible for the study.400 vitamin D deficient women will be randomly allocated to either one of two groups. The first group will receive vitamin D supplementation in addition to the routine care. The other group will receive the routine care only. The study will be conducted in the IVF unit of department of Obstetrics and Gynecology, Cairo University.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D supplement	Experimental	This group will receive weekly oral 50000 international units of vitamin D supplement for 8 weeks before the start of ICSI cycle. In addition, the routine care will be given.	Drug: Vitamin D
Routine care	No Intervention	This group will receive the routine care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Drug	Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred	Vitamin D supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate	This outcome will be calculated by a statistician	It will be calculated 1 year after enrollment of the first patient in the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Vitamin D deficient females undergoing first ICSI trial
Age from 20 to 35 years

Exclusion Criteria:

Women undergoing ICSI trials who are vitamin D sufficient

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eman Omran, M.D.	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital		Cairo	Greater Cairo	11956	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D
D002117	Calcitriol

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided