Infertility is clinically described as a disease of the reproductive system defined by failure to achieve pregnancy after 12 months or more of regular unprotected sexual intercourse [1] affecting 9%-15% of couples worldwide [2]. It is estimated that 1.9 and 10.5 % of women aged 20-44 years worldwide suffer from primary and secondary infertility, respectively [3]. In the journey of seeking treatment, about 3 % of infertile couples resort to assisted reproductive technology (ART), of which in vitro fertilization (IVF) accounts for more than 99 % [4]. While infertility is a long-term source of stress that affects couples in their existential, physical, emotional and interpersonal domains [5], IVF treatment is likely to cause anxiety with its distressing nature in terms of physical discomfort and depression with uncertainty about the outcome of treatment [6]. 

The experience of infertility for an individual can affect their entire existence as mentioned above, affecting their perceptions and experiences of physical, spiritual, emotional, sexual and psychological well-being [7, 8]. Research has shown that medical intervention to treat infertility causes significant psychological and social stress in one's life [9]. A cycle of treatment for a woman often consists of medications that stop the natural menstrual cycle and replaces it with synthetic and natural hormones to stimulate the ovaries and produce eggs. This broad change in hormonal function is often described by women as experiencing intense feelings of hope one moment and intense despair the next [10,11,12, 13]. At the beginning of each cycle of IVF treatment there is great hope and expectation of pregnancy success. In the middle of the cycle near ovulation, hormonal changes affect emotional regulation and anxiety associated with the procedures. The onset of a menstrual cycle after an IVF attempt is often associated with depression [12]. Infertility in general can cause psychological distress, emotional distress and financial difficulties for both partners [14]. Typical reactions to infertility include shock, sadness, depression, anger and frustration, loss of self-esteem and self-confidence, and a general loss of sense of control [6]. Although infertility is not a life-threatening issue, it is still considered a stressful life experience for couples. The high stress of infertility can be attributed to the fact that having a child is considered important in the general society [15].

Moreover, infertile couples often hide their feelings, ideas and beliefs because infertility is still considered a private issue. Therefore, infertile couples may be exposed to social pressure. In addition, an individual relationship with their partner as well as that with friends and family members may suffer. These family members or friends may provide meaningful opinions and suggestions that may cause further distress [2].

Most research concludes that psychological stress primarily affects the partner experiencing the fertility problem [16,17]. Infertility is a stressful life event and depressive symptoms are normal responses to the life crisis of the infertile couple. Grief reactions are common among infertile women and men and the grieving process is considered important in resolving the infertility crisis [18].

Greek Studies

In Greece, some attempts have been made to investigate anxiety and depression in relation to infertility. However, these are more focused on how stress and psychology in general affects the outcome of IVF, such as for example the thesis of Gouroundi [19] on "Investigation of the impact of psychosocial factors on stress in infertility and the outcome of assisted reproduction and the impact of the mode of conception on stress levels in pregnancy; suggestions for supportive care" at Panteion University, Social and Political Sciences, Department of Psychology. Another study studying stress is that of Gourounti, Lykeridou and Vaslamatzis. [20], entitled "Increased anxiety and depression in Greek infertile women results from feelings of marital stress and poor marital communication". An additional study again concerning the female side, entitled "Experience of infertile Greek women undergoing IVF" by Sarantaki, Gourounti and Lykeridou [21]. Participants described experiencing their infertility with feelings of insecurity, surprise and failure of their gender role. Social pressure and social isolation were reported as effects of infertility. The majority of participants had high expectations regarding the IVF process and a strong desire to continue attempts despite the hope-disappointment cycle. A study of the couple's psychology of both the woman and the man together on the attempt to achieve pregnancy by IVF has not been carried out to date.

International studies

The emotional reactions of infertile couples and the effect they have on each other have been recognised [22]. Although men were usually less involved in infertility treatment procedures, they also suffered from IVF treatment together with their partner as an infertile couple. Studies on men's psychological state before, during and after the IVF cycle have also been presented in several studies [23, 24]. As the socialization process and the expected gender role of men are different from those of women, one would expect gender differences in response to IVF treatment. However, there is no review comparing differences in travel between men and women undergoing IVF treatment. The psychological well-being of men is often neglected and also deserves attention.

A study of couples in Iran published in 2005 in the Journal of research medical sciences (JRMS) , [25] showed that about 10% of Iranian couples wishing to have a child may experience a significant psychological burden. The main objective of this synchronic study was to examine the level of anxiety and depression among infertile couples undergoing IVF or ICSI treatment cycles in Iran. Fifty infertile couples who underwent IVF cycles were examined for this descriptive study. Compared with controls, the highest rates of moderate and severe anxiety were observed in women who underwent IVF (76% and 12%, respectively, P<0.05). However, the rate of depression among women in the IVF group was comparable to women undergoing ICSI. Also, the highest rates of severe depression and anxiety were demonstrated among housewives (23.9% and 11%, respectively). The lowest rates of severe anxiety and depression were observed in husbands who participated in either IVF or ICSI cycles. In addition, illiterate, compared to educated couples, who underwent IVF or ICSI appeared to have the highest rates of both depression and anxiety. In conclusion, the results showed that levels of anxiety and depression were higher in women, particularly housewives, undergoing IVF or ICSI cycles compared to controls. Also, men had lower rates of anxiety and depression than women who underwent IVF or ICSI. Therefore, this may provide useful information and guidance for healthcare professionals working with infertile patients. Another relevant study is that of Benyamini, Gozlan, Kokia [26] published in February 2009 in the British journal of health psychology entitled "Women's and men's perceptions of infertility and their associations with psychological adjustment: a binary approach".The aim of this study was to extend this research to the study of couples, examining perceptions of infertility among couples undergoing treatment and their associations with the psychological adjustment of each partner. The study was a combined study and included two samples that differed in stage of treatment: Sample 1 included 72 couples at their first visit to an infertility clinic and sample 2 included 49 couples at various stages of treatment. Participants completed the Illness Perception Questionnaire about the timing, consequences and controllability of their fertility problem and the Specific Infertility Distress and Wellbeing Scales.  The companions differed in their perceptions of infertility and their distress. The psychological adjustment of partners was related to their perceptions of their fertility problem. Among couples at their first visit, both partners' perceptions of consequences were additionally related to their distress, while perceptions of control interacted in their association with female distress.

Women's depression levels before undergoing IVF treatment were reported in seven studies abroad. Five of these studies revealed that compared to fertile women, infertile women reported more symptoms of depression. In a study among husbands in Israel. by Merari, Chetrit & Modan [27], emotional reactions and husband's attitudes to in vitro fertilization (IVF) treatment were examined. The participants were 113 childless couples suffering from infertility of unknown cause. Both partners were evaluated before IVF treatment. Incompatible emotional reactions and attitudes to treatment between partners typically reflected men reporting less distress and anxiety than women. Women had significantly higher anxiety and depression scores than typical levels, regardless of whether conception was successful. Wives who had not conceived had depression and anxiety scores much lower than the normal level. In addition, high emotional responses to treatment, especially in men, were positively associated with treatment success. Based on these results, recommendations for family assessment and counseling are suggested.

Four studies examined stress levels in men during the treatment period prior to IVF. Two studies identified differences in anxiety, with men in infertile couples having higher levels of anxiety than fertile men. The levels of trait anxiety in men in the pre-treatment period were not higher than the norm [27]. Another study comparing men and women of 160 couples prior to undergoing IVF treatment found that women scored significantly higher than men on stress (STAI-S, m = 32.8 vs. 30.4) and perceived stress (PSS, m = 11.2 vs. 9.9) [28]. The most recent study available [29] is on the effect of psychological distress on IVF outcomes and involves 304 infertile women in three different cities in Kazakhstan. Its results were that Rates of stress, anxiety and depression among IVF patients are higher than in the general population. If the level of stress associated with infertility is higher, the success rate of IVF is lower.

In summary, studies that examined the emotional states of individuals and couples during the treatment period before IVF revealed that women had higher levels of depression and anxiety. Men in general also had increased levels of depression, while results on anxiety levels were inconsistent, with some showing increased levels of anxiety and others reporting no differences among infertile men.

Aim: The main purpose of this study is to investigate the levels of anxiety and depression in infertile couples during the initiation of their first IVF attempt.

Particular Objectives

• To identify any gender differences in levels of anxiety and depression.
• To investigate how and whether demographic characteristics (gender, age, educational level, occupation, time period of attempting to achieve pregnancy) are associated with the occurrence of anxiety or depression prior to IVF.

Research Hypotheses

Based on the literature data, the following hypotheses were formulated:

• Anxiety and/or depression plays a decisive role in the continuation or not of treatment, as psychological factor is a key reason why a couple withdraws from IVF programme.
• Do women experience more stress than their husbands? Are levels of depression similar between the two husbands?
• Does infertility affect the quality of life of both the man and the woman?

The Importance of The Study and Its Relevance

 Infertility is a condition that has existed since the old days and they just didn't give it a name because they didn't have the proper knowledge and methods that exist today to combat it. When a couple tried to have a child and ultimately failed, there remained to this day a social stigma attached to the couple and they were labelled as "hard up", or having a "vice" which had a negative impact not only on the mental health of the couple but also on their relationship with each other. Social stereotypes have always been an occasion for social commentary, criticism and the placing of labels on people. All the more so when it is a couple who want to have a child and cannot. In modern society and even in a country like Greece, we cannot say with certainty that these phenomena have completely disappeared, but what is certain is that the scientific knowledge required to understand and deal with infertility to a large extent, such as assisted reproduction, has now been acquired. What has not been studied is the endurance and mental strength of a couple who are reproductively ill and how this affects the daily lives of both partners. This study will accurately document the magnitude of the problem and suggest the appropriate tools for the implementation of interventions (information and prevention programmes) by mental health professionals and infertile couples who make the final decision (decision makers). Based on the results of the study, efforts will be made to design and implement an intervention plan for part of the study population. The purpose of these intervention/prevention programs is to alleviate the emotional symptoms of mental stress and emotional burnout experienced by a couple until they reach, if ever, the desired outcome i.e. a pregnancy and a healthy child. As a scientific project, this study will hopefully enrich the scientific literature in this field.  

This study will provide a better understanding of couples' emotional reactions and provide health professionals with the information they need to help infertile couples through a vulnerable stage in their lives. It may also lead to future research in related fields.

Research Design

In this research study, descriptive study will be chosen as the most appropriate to answer the research questions, which is a type of quantitative study. Descriptive study explores and describes phenomena in real conditions. It helps researchers to find new meanings, describe what is there and determine the frequency with which a situation occurs [30]. The researcher has no control over the occurrence or evolution of the phenomenon observed, since he or she aims to describe the relationships between the information being examined and draw conclusions about the causes of the various phenomena.

Place Where the Study Is to Be Carried Out

The study will be conducted in infertile couples on the day of the start of the IVF protocol coinciding with the first ultrasound at the beginning of the woman's cycle in the gynecology clinic. More specifically, the study will be conducted in a private gynecological clinic in Athens, specializing in infertility and its treatment. The multiple daily cases/couples seeking a solution to infertility make this clinic the most suitable place to conduct the research as it provides both a plethora of cases and diversity as every couple that comes to it is different.

Sample

The sample will be infertile couples trying to achieve pregnancy for the first-time using IVF. The total sample expected to be included in the study is estimated at 50 couples.

Exclusion Criteria

The following will be excluded from the study

• Couples who already have a child.
• Couples who have previously tried IVF.
• Couples who have experienced a miscarriage in the past.
• Couples who have undergone gamete donation cycles, i.e. egg and sperm donation.

Procedure for The Collection of Data

The data of the study will be collected through the procedure of anonymous questionnaires (self-report method), which is considered as the most appropriate for collecting data related to opinions, attitudes, beliefs, values. The study protocol will be submitted for approval to the private practice .

Questionnaires will then begin to be administered along with written instructions and a written consent form for study participants.

Measurement Tools-Questionnaires

The questionnaires decided to be used for the needs of the survey are four in number.

• The first questionnaire, FertiQoL [31], measures the quality of life of fertility in men and women experiencing fertility problems. The World Health Organization (WHO) in 1998 defined quality of life (QoL) as "...an individual's perceptions of his or her place in life in the context of the culture and value systems in which he or she lives and in relation to his or her goals, aspirations, norms and concerns...". Therefore, quality of life is a subjective assessment of the excellence of an individual's life embedded in his or her cultural, emotional, social and environmental context. The FertiQoL is a sensitive, reliable and valid measure of quality of life for men and women experiencing fertility problems. The European Society for Human Reproduction and Embryology (ESHRE) and the American Society for Reproductive Medicine (ASRM) joined forces with Merck-Serono, Geneva, Switzerland (a subsidiary of Merck, Darmstadt, Germany) to create FertiQoL (2002-2009). The overall objective of the FertiQoL project was to develop an international tool to measure quality of life in men and women experiencing fertility problems. It consists of 36 items assessing core (24 items) and treatment-related quality of life (QoL) (10 items) and overall life and physical health (2 items). The 36 FertiQoL items are scored according to a five-point response scale. Higher scores for subcategories and overall scores indicate better quality of life.
• The second questionnaire for this study is The State-Trait Anxiety Inventory (STAI)[32] is a widely used measure of trait and state anxiety. It is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - situational anxiety or anxiety about an event and trait anxiety or the level of anxiety as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
• The third questionnaire is the Demographic and Personal Data questionnaire. The study of the relevant literature, the type of study and the purpose of the study determined the need for the researcher to create a questionnaire. It includes 5 questions. The participants will have to answer about their age, gender, occupational status, educational level and how long they have been trying to achieve pregnancy.
• Questionnaire to investigate depression the Zung Self-Depression Self-Assessment Scale (SDS) [33,34] which consists of 20 items with a Likert-type scale after each item. It was designed to quantify a patient's level of anxiety; the scores for each item range from 1 to 4... As for the Greek translation of the questionnaire to be used in this study, its validity has been investigated [35].

Reliability and Validity of questionnaires

The feasibility of the questionnaires will be assessed by calculating the missing values of the various items, i.e. by calculating the number of responses that will not be given to these items.

Reliability with regard to the criterion of stability of results refers to the extent to which the items of a scale account for the same dimension and is measured by calculating the Cronbach's coefficient a. By reliability of a psychometric instrument we mean its ability to produce the same results through procedures of repeated measurements, which are carried out on the same experimental subjects and under the same conditions [36].  In the present study, the measurement of internal consistency reliability was carried out by calculating the Cronbach's coefficient α for the results of the questionnaires. This calculation is carried out by applying a statistical test in which it is assessed whether the items of a scale are positively correlated with each other (for example, when they measure the same thing). Scales with reliability greater than or equal to 0.70 are recommended for comparing 2 groups of patients, while reliability greater than 0.90 is recommended for analysing individual patient outcomes [37]. The concept of validity refers to the ability of a psychometric instrument to measure what it is intended to measure.

Data Processing-Statistical Analysis

Qualitative variables will be described in terms of absolute and relative frequency. The chi-squared test (χ2) will be used to test the correlation between them. The mean and standard deviation will also be used for a descriptive picture of the data. To compare the quality of life fertility, anxiety levels and depression levels between men and women, the parametric analysis of variance (ANOVA) or parametric t-test will be utilized as we are referring to two groups so that the two tests are equivalent. To correlate anxiety and depression with demographic factors, logistic regression method will be utilized. Statistical significance will be set at 0.05 (95% confidence interval) . The analysis will be performed using the statistical package IBM SPSS STATISTICS 25. Ensuring a satisfactory response rate will be achieved by continuous supervision of the researcher in terms of data collection and completion of questionnaires.

Ethical Issues

There are no potential risks in this study. The questionnaires used will be anonymous and at no point will they include questions that could under any circumstances lead to the identification of the respondent. Measures will be taken to ensure confidentiality and other rights in accordance with the Declaration of Helsinki and as amended in Tokyo in 2004 [38] and then in Brazil in 2013 [39] and finally in accordance with the application of the Personal Data Protection Act of the EU Regulation 2016/679 and in particular Article 19 amended in 2018, on the processing of personal data for scientific or historical research purposes or statistical purposes [40]. These data will remain strictly for the use of statistical data processing [39].

 It will also be impossible to identify the structures (hospitals) in which the questionnaires will be completed and will be subject to direct coding. These data will remain strictly for the use of statistical data processing. The couple will be informed and their consent will be sought in writing before starting to complete the questionnaires. The participant will have the option not to answer any question for any reason. The primary material (completed questionnaires) that will be obtained will remain strictly for the use of the researcher and the supervising teacher and will not be given for any purpose to a third party, during and after the research study.

The survey will start immediately after the approval has been granted.

The investigation of anxiety and depression in infertile couples who start the IVF procedure reveals the great psychological burden that these individuals face. The findings highlight that infertility, combined with anxiety about the success of IVF, can lead to severe emotional problems, particularly for women. The psychological burden is further exacerbated by previous failed attempts and by the prolonged duration of infertility.

The study highlights the urgent need for the creation of support structures and psychological assistance for infertile couples, particularly during the IVF process. Providing counselling, developing coping mechanisms and strengthening social support can help to reduce anxiety and depression, improving the mental well-being and, by extension, the quality of life of these couples.

Psychological care should be considered an integral part of assisted reproduction in order to create a supportive environment that will enhance couples' strength and resilience, increasing the chances of a successful outcome of their treatment.

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