StressNCT05681130
Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success
An observational study of Stress and Pregnancy, run by Eurofertil IVF Health Center at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- What is being tested?
- questionaire
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 17 Feb 2024
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- 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.
Who may be able to join
- 20 to 40 year old women attending to IVF programme
Who cannot join
- Azospermia and severe male factor for whom sperm freezing will be required
- History of RIF
- Known genetik abnormality of couples
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- questionaire
- Keywords
- depression, anxiety, stress, pregnancy, IVF
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaireOther
two questionaires for each group
| Study group | Role | What they receive |
|---|---|---|
| 1 women attending IVF programme | Women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure Receives: 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 Receives: Other: questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive pregnancy test
blood test will be taken after embryo (blastocyst) transfer
Measured: 12 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Mar 2022
- Primary completion17 Feb 2024
- Study completion17 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Eurofertil IVF Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- gerçek aydın, Study director, Eurofertil IVF Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681130
- Sponsor's protocol ID
- IVF- Stress
- Status last verified
- Feb 2024
- First submitted
- 27 Dec 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be evaluated upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success
- ClinicalTrials.gov ID
- NCT05681130
- Acronym / sponsor ID
- IVF- Stress
- Keywords
- depression, anxiety, stress, pregnancy, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Eurofertil IVF Health CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 women attending IVF programme | – | Other: questionaireWomen attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure |
| 2 partners of women attending to IVF programme | – | Other: questionaireMen who are partners of women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 20 to 40 year old women attending to IVF programme
Key exclusion criteria (3 listed)
- Azospermia and severe male factor for whom sperm freezing will be required
- History of RIF
- Known genetik abnormality of couples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionairetwo questionaires for each group | Other | 1 women attending IVF programme, 2 partners of women attending to IVF programme |
Primary outcome
positive pregnancy test
Time frame: 12 days after embryo transfer
blood test will be taken after embryo (blastocyst) transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided. will be evaluated upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gerçek aydın study director
Eurofertil IVF Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Pregnancy, run by Eurofertil IVF Health Center at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive pregnancy test (time frame: 12 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.