NCT02365337

Brief Summary

The aim of this study is observing the relation between serum Vitamin D levels and morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor infertility. Individuals will be divided into 2 groups according to serum vitamin D levels as normal or low , and the influence of those levels in morphokinetic parameters of embryos will be identified.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

February 9, 2015

Last Update Submit

January 27, 2016

Conditions

Keywords

Vitamin Dtime lapse monitoringembryo

Outcome Measures

Primary Outcomes (1)

  • time to 2 pronucleus (PN) membrane breakdown, first cleavage and 3, 4, 5, 6, 7, and 8 cells stages, morula and blastocyst stage (t2, t3, t4, t5, t6, t7, t8, t Morula (M), t Blastocyst (B) )

    between 17 and 120 hours

Study Arms (2)

vitamin D levels < 20ng/ ml

Vitamin D levels \< 20ng/ ml

vitamin D levels>20ng/ ml

Vitamin D levels \>20ng/ ml

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

participants will be recruited among infertile women who is seeking for IVF treatment and fullfilling the inclusion criteria.

You may qualify if:

  • years to 38 years age, 2 or less in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI) attempt history, Unexplained or tubal factor infertility, Serum Follicle Stimulating Hormone (FSH) \< 10, Antral Follicule Count (AFC)\> 6-8

You may not qualify if:

  • Male factor infertility, Presence of endometriosis or adenomyosis,Diminished ovarian reserve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceci Fulya IVF Center

Istanbul, Fulya, 34800, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Mullerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012 Jul;97(7):2450-5. doi: 10.1210/jc.2012-1213. Epub 2012 Apr 16.

    PMID: 22508713BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

kubra n boynukalin

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 18, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations