NCT02822872

Brief Summary

Infertile couples who come for evaluation and treatment in IVF unit could be under psychological stress. Many authors in the past suggested that stress itself is one of the factors that directly influence fecundability rate. In couples treated in IVF unit, the investigators aim to measure chronic stress by measuring hair cortisol level (as a marker for chronic cortisol release) and by filling different questionnaires.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Status
unknown

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 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 4, 2016

Status Verified

June 1, 2016

Enrollment Period

1.6 years

First QC Date

June 28, 2016

Last Update Submit

July 1, 2016

Conditions

Healthy

Keywords

infertilitystressscalp haircortisol

Outcome Measures

Primary Outcomes (1)

  • concentration of scalp hair cortisol level during IVF treatment (nmol/L)

    Hair scalp cortisol will be assessed at couples admission to the investigators IVF unit and at 3 months intervals until pregnancy is achieved

    3 months

Secondary Outcomes (1)

  • stress assessment during IVF treatment by using questionnaire

    3 months

Study Arms (1)

infertile couples

couples addressing IVF treatment due to known infertility will fill questionnaire in order to assess their stress level (as mentioned above), after filling the questionnaire scalp hair sample will be taken to assess chronic cortisol secretion. during the IVF treatment the stress level will be assessed every 3 month by using the same system (in order to find match between the stress level and cortisol secretion with the fertility treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy couple with known infertility from any reason (both male and female pathology and for unknown infertility) who addressing IVF treatment in Bnai zion medical center.

You may qualify if:

  • infertile couples who addressing IVF treatment in the investigators institute.

You may not qualify if:

  • couple who don't want to precipitate.
  • when there isn't hair to sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Scalp hair

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Eyal levy, MD

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EYAL LEVY, MD

CONTACT

+972544326526levyeyal_il@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetric and gynecology resident

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 4, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 4, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share