Relation Between Emotional Stress and Infertility

NCT ID: NCT02822872

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-02-28

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eyal.levy

Obstetric and gynecology resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyal levy, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Central Contacts

EYAL LEVY, MD

Role: CONTACT

levyeyal_il@yahoo.com

+972544326526

Other Identifiers

0107-15-BNZ

Identifier Type: -

Identifier Source: org_study_id