NCT02209168

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

June 27, 2014

Last Update Submit

August 31, 2018

Conditions

Female Infertility Due to Diminished Ovarian ReserveVitamin D DeficiencyHormone DeficiencyFollicular Cyst of Ovary

Keywords

AMH, ACF, VIT D, Ethnicity

Outcome Measures

Primary Outcomes (1)

  • Ovarian reserve markers: antimullerian hormone, FSH, antral follicle count

    beginning of the treatment cycle

Secondary Outcomes (1)

  • Serum vitamin D levels

    Beginning of their treatment cycle

Study Arms (3)

Infertile Indian Population

200 Infertile Indian population

Infertile arabian population

200 Infertile Arabian population

Infertile caucasian population

200 Infertile Caucasian population

Eligibility Criteria

Age21 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • POLYCYSTIC PATIENTS ENDOMETRIOSIS GRADE III OR IV INFLAMMATORY PELVIC DISEASE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Madrid

Madrid, 28023, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vitamine D serum levels.

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • CARLOS IGLESIAS, MD

    IVI Madrid

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carlos Iglesias, MD

Study Record Dates

First Submitted

June 27, 2014

First Posted

August 5, 2014

Study Start

November 1, 2015

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

September 4, 2018

Record last verified: 2018-08

Locations

ES(1)