HealthySFTNCT02822872
Relation Between Emotional Stress and Infertility
An observational study of Healthy, run by Bnai Zion Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Feb 2018
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- infertile couples who addressing IVF treatment in the investigators institute.
Who cannot join
- couple who don't want to precipitate.
- when there isn't hair to sample.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Many speculations regarding the decline in human fecundity are believed to be related to environmental factors, including life style. Among many other factors, perceived psychological stress has been suggested to alter both male and female fertility.
There are many ways to asses stress, one of which is done by filling questionnaires. DASS-21, a 21-item questionnaire, is a set of three self-report scales (Depression, anxiety, stress scale). The negative emotional states of depression, anxiety and stress can be measured using DASS21.
Each of the three DASS scales contains 7 items. Each item is rated on a four-point scale of severity. By using DASS scale, stress and anxiety level of the subject can be monitored in different situations in life.
Another way to asses stress can be done by measuring peptides that are secreted in acute and chronic stress, one of them is cortisol.
Cortisol is a glucocorticoid class steroid hormone; it is produced in humans by the zona fasciculate of the adrenal cortex within the adrenal gland. It is quantified as a marker for hypothalamic pituitary adrenal axis reactivity. In humans, cortisol levels are increased in stress, depression, and selected systemic diseases such as Cushing's syndrome as well as in response to low blood-glucose concentration as well as a response to psychosocial stress.
The experience of chronic adversity or stress is well-known to be associated with a range of negative effects on health. A crucial neuroendocrine axis involved in mediating these effects is the hypothalamus pituitary adrenal axis leading to the secretion of the glucocorticoid cortisol.
Measurement of long-term endogenous production of cortisol can be done by taking urine, saliva or serum samples, while each of these measurements has advantages and limitations. All these methods require multiple samples to provide an assessment of cortisol levels over prolonged periods of time and it is important to note that those measures reflect acutely circulating cortisol level or integrated cortisol secretion over the examined sampling period. Another aspect is that acute cortisol level fluctuates markedly depending on many factors such as circadian rhythmicity, acute stress, cigarettes smoking, alcohol, or exercising.
Another strategy is to measure cortisol is a repeated sampling at different time of the day over several days. But, in order for this strategy to be effective, large number of sampling points during the day are needed.
Taking together, real assessment of long term cortisol secretion can be difficult, thus a new technique has been developed using hair. Positive association between hair cortisol and accumulated salivary free cortisol was seen, and it was concluded that hair cortisol reflects long term cortisol secretion.
In infertile couples who come for evaluation facing stressful time that can cause an even more reduction in fecundity, the investigators will measure long term cortisol secretion and understand the effect of stress and cortisol on infertile couples.
- Conditions
- Healthy
- Keywords
- infertility, stress, scalp hair, cortisol
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
stress assessment during IVF treatment by using questionnaire
Stress assessment using questionnaire will be filled by the couples with each of the scalp hair collection (at admission and in 3 months interval until pregnancy is achieved)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eyal.levy, Bnai Zion Medical Center
- Investigators
- Eyal levy, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822872
- Sponsor's protocol ID
- 0107-15-BNZ
- Acronym
- SFT
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Emotional Stress and Infertility
- ClinicalTrials.gov ID
- NCT02822872
- Acronym / sponsor ID
- SFT / 0107-15-BNZ
- Conditions
- Healthy
- Keywords
- infertility, stress, scalp hair, cortisol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Jul 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 4 Jul 2016 (estimated)
- 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.
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.
Detailed description
Many speculations regarding the decline in human fecundity are believed to be related to environmental factors, including life style. Among many other factors, perceived psychological stress has been suggested to alter both male and female fertility.
There are many ways to asses stress, one of which is done by filling questionnaires. DASS-21, a 21-item questionnaire, is a set of three self-report scales (Depression, anxiety, stress scale). The negative emotional states of depression, anxiety and stress can be measured using DASS21.
Each of the three DASS scales contains 7 items. Each item is rated on a four-point scale of severity. By using DASS scale, stress and anxiety level of the subject can be monitored in different situations in life.
Another way to asses stress can be done by measuring peptides that are secreted in acute and chronic stress, one of them is cortisol.
Cortisol is a glucocorticoid class steroid hormone; it is produced in humans by the zona fasciculate of the adrenal cortex within the adrenal gland. It is quantified as a marker for hypothalamic pituitary adrenal axis reactivity. In humans, cortisol levels are increased in stress, depression, and selected systemic diseases such as Cushing's syndrome as well as in response to low blood-glucose concentration as well as a response to psychosocial stress.
The experience of chronic adversity or stress is well-known to be associated with a range of negative effects on health. A crucial neuroendocrine axis involved in mediating these effects is the hypothalamus pituitary adrenal axis leading to the secretion of the glucocorticoid cortisol.
Measurement of long-term endogenous production of cortisol can be done by taking urine, saliva or serum samples, while each of these measurements has advantages and limitations. All these methods require multiple samples to provide an assessment of cortisol levels over prolonged periods of time and it is important to note that those measures reflect acutely circulating cortisol level or integrated cortisol secretion over the examined sampling period. Another aspect is that acute cortisol level fluctuates markedly depending on many factors such as circadian rhythmicity, acute stress, cigarettes smoking, alcohol, or exercising.
Another strategy is to measure cortisol is a repeated sampling at different time of the day over several days. But, in order for this strategy to be effective, large number of sampling points during the day are needed.
Taking together, real assessment of long term cortisol secretion can be difficult, thus a new technique has been developed using hair. Positive association between hair cortisol and accumulated salivary free cortisol was seen, and it was concluded that hair cortisol reflects long term cortisol secretion.
In infertile couples who come for evaluation facing stressful time that can cause an even more reduction in fecundity, the investigators will measure long term cortisol secretion and understand the effect of stress and cortisol on infertile couples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- infertile couples who addressing IVF treatment in the investigators institute.
Key exclusion criteria (2 listed)
- couple who don't want to precipitate.
- when there isn't hair to sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concentration of scalp hair cortisol level during IVF treatment (nmol/L)
Time frame: 3 months
Hair scalp cortisol will be assessed at couples admission to the investigators IVF unit and at 3 months intervals until pregnancy is achieved
1 secondary outcome
stress assessment during IVF treatment by using questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
Eyal levy, MD principal investigator
Bnai Zion Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Bnai Zion Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EYAL LEVY, MD (+972544326526, levyeyal_il@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of scalp hair cortisol level during IVF treatment (nmol/L) (time frame: 3 months). 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 4 Jul 2016.