Effect of Depression, Anxiety and Stress Scores on Embryo... | NCT05681130

Studies
Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success

NCT05681130

Sponsor

Eurofertil IVF Health Center

Status

Completed

Last Update Posted

Feb 20, 2024Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Stress
Pregnancy

Interventions

questionaire

Countries

Turkey (Türkiye)

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

Feb 2024

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

Mar 1, 2022Actual

Primary Completion Date

Feb 17, 2024Actual

Completion Date

Feb 17, 2024Actual

First Submitted Date

Dec 27, 2022

First Submission Date that Met QC Criteria

Dec 27, 2022

First Posted Date

Jan 12, 2023Actual

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

Feb 17, 2024

Last Update Posted Date

Feb 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Psychological status of couples attending to IVF programmes is important due to possible effect on final result. Observers aim to investigate the depression, anxiety and stress scores of couples before and after the procedure.

Detailed Description

Studying effect of psychology on IVF is not a new idea. "Before and after" scores of women attending to IVF programmes had been studied numerous times. However, there is not sufficient data about the contbibution of male compartment upon the process. Investigators aimed to study both male and female participants. Final scores will not be evaluated unless at least good quality blastocsyt is transferred.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 women attending IVF programme		Women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure	Other: questionaire
2 partners of women attending to IVF programme		Men who are partners of women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure	Other: questionaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionaire	Other	two questionaires for each group	1 women attending IVF programme 2 partners of women attending to IVF programme

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
positive pregnancy test	blood test will be taken after embryo (blastocyst) transfer	12 days after embryo transfer

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20 to 40 year old women attending to IVF programme

Exclusion Criteria:

Azospermia and severe male factor for whom sperm freezing will be required
History of RIF
Known genetik abnormality of couples

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

reproductive aged women

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women ages 20-40, without history of RIF or known genetic aneuploidy. Men without severe sperm problem without known genetic aneuploidiy. Only blastocyst transferred copules will be eligible for final analysis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
gerçek aydın	Eurofertil IVF Health Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eurofertil		Bursa		16000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

will be evaluated upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided