Differences in Ovarian Reserve Markers and Vitamin D Betw... | NCT02209168

Studies
Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population

NCT02209168

Sponsor

IVI Madrid

Status

Withdrawn

Last Update Posted

Sep 4, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Female Infertility Due to Diminished Ovarian Reserve
Vitamin D Deficiency
Hormone Deficiency
Follicular Cyst of Ovary

Interventions

Not provided

Countries

Spain

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Jun 27, 2014

First Submission Date that Met QC Criteria

Aug 1, 2014

First Posted Date

Aug 5, 2014Estimated

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

Aug 31, 2018

Last Update Posted Date

Sep 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 confirm the difference in ovarian reserve markers and serum vitamine D levels between infertile indian, arabian and caucasian population.

Detailed Description

200 caucasian, indian, and arab patients

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

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infertile Indian Population		200 Infertile Indian population
Infertile arabian population		200 Infertile Arabian population
Infertile caucasian population		200 Infertile Caucasian population

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovarian reserve markers: antimullerian hormone, FSH, antral follicle count		beginning of the treatment cycle

Secondary Outcomes

Measure	Description	Time Frame
Serum vitamin D levels		Beginning of their treatment cycle

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT

Exclusion Criteria:

POLYCYSTIC PATIENTS ENDOMETRIOSIS GRADE III OR IV INFLAMMATORY PELVIC DISEASE

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERTILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CARLOS IGLESIAS, MD	IVI Madrid	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IVI Madrid		Madrid		28023	Spain

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided