2.1 Study design
A cross-sectional survey was conducted among women who are undergoing in vitro fertilization (IVF) treatment, from June 15, 2023 until September 8, 2023 in Lebanon. The questionnaire was completed by the women themselves after receiving it via WhatsApp from their treating doctor.
To ensure clarity, the questionnaire was pilot-tested on ten women, and the resulting data were incorporated into the final database. Participation was entirely anonymous and voluntary, and participants did not receive any compensation for their involvement in the study.
2.2 Inclusion and exclusion criteria
The inclusion criteria were as follows: Lebanese woman of reproductive age (18 years and above) diagnosed with infertility, regardless of whether she is the source of infertility, currently residing in Lebanon, and undergoing in vitro fertilization (IVF) treatment.
The exclusion criteria were as follows: individuals with cognitive impairment that may hinder their ability to understand and respond accurately to the study questionnaire, as well as those diagnosed with severe psychological illnesses including anxiety and depression.
2.3 Sample size calculation
The minimum sample size was calculated using the G-Power software, version 3.0.10. Anticipating a squared multiple correlation of 0.05 (R2 deviation from 0) in regard to the Omnibus test of multiple regression, the computed effect size was 0.0526. The minimum necessary sample was n=371, considering an alpha error of 5%, a power of 80%, and allowing 15 predictors to be included in the model. An overall sample of 400 participants would be collected to take potential missing values into account.
2.4 Selection procedure
The recruitment strategy involved collaboration with fertility clinics in Lebanon to draw participants from their patient pool. Additionally, the study was shared by 23 fertility doctors from various regions in Lebanon, all practicing in certified IVF centers approved by the Lebanese Medical Syndicate. Among these doctors, three had ceased IVF practice, three were unavailable during the study period, and eight were working abroad. However, nine doctors agreed to distribute the survey to their patients, ensuring coverage across all Lebanese regions, including Beirut, Mount Lebanon, North, South, and Beqaa.
Woman who participated in the study are those who filled in a link received, by their doctor, on their mobile phone through the "WhatsApp" application. The distribution was expanded through the "sharing" option, to reach 403 participants. Initially, doctors were first contacted via a phone call, and subsequently, researchers visited their clinics to facilitate their involvement in the study.
2.5 Data collection procedure
The online survey consisted of closed- ended questions in English and Arabic. The questionnaire was developed on Google Forms, and the link was distributed through WhatsApp.
First, a questionnaire was developed to meet the objectives of the study. Standardized questionnaires that measured quality of life, couple’s satisfaction, patient-doctor relationship and well-being were used. This questionnaire was transformed into a form on "Google form" in accordance with the required conditions, and this after a double translation from English to Arabic according to the WHO translation guidelines. Subsequently, the form including the questions necessary for data collection was saved as a link (https://docs.google.com/forms/d/e/1FAIpQLSeuNUcOiGUuJyDTR6xKDal1b0qbXBp6uQUzjLfeFx1sB7kxXA/viewform?usp=sf_link ) to be distributed as described in the previous paragraph. The construction of the questionnaire requires participants to answer all the questions in order to be able to proceed and this to avoid missing data. Once the form was completed and submitted, the results were recorded spontaneously on an answer sheet for further statistical analysis.
2.6 Questionnaire and variables
Primary variable: Quality of life of Lebanese women undergoing IVF, which can be measured using a standardized questionnaire: FertiQoL.
Secondary variables:
Socio-Demographic variables: Age, education level, occupation, and geographic location, hobby, type of work and income, physical activity (sport), living near family members, quality of the marital relationship, access to support from family and friends (social support), access to infertility counseling and support groups, religious or cultural beliefs related to fertility and IVF, Household income, relationship with the health care provider.
Infertility-related variables: Duration of infertility, cause of infertility, and number of IVF cycles, type of infertility (male factor, female factor, combined, unexplained), use of additional fertility treatments or medications (such as IUI, ovarian stimulation drugs), pregnancy outcome (successful or unsuccessful), adverse effects experienced during IVF treatment, success rate of IVF (pregnancy and live birth rates), number of embryos transferred, time since last IVF cycle, use of donor gametes (egg or sperm), previous history of pregnancy or miscarriage, treatment protocol, access to information about IVF.
Health-related variables: Presence of comorbidities, pregnancy complications, mode of delivery of previous pregnancy if applicable, alcohol consumption, smoking, medical history (e.g. PCOS, endometriosis, thyroid disorders) and surgical history, weight, height, alimentation, medication, Mental health status (such as anxiety and depression), presence of children.
2.7 Questionnaire
This questionnaire was constructed after reviewing the prior literature. It includes 5 sections with duration of completion: 10-15 minutes. The content is displayed in appendix 1.
Section 1: Consent: In the preamble, a brief explanation of the objective of the study with identification of the researchers, a clarification of ethical rights, respect for anonymity and confidentiality, and the right to withdraw before submitting the answers. The form was constructed so that informed consent was a mandatory statement to be clicked in order to continue browsing and answering questions.
Section 2: Including demographic variables, infertility-related variables, health-related variables and others. In addition, the WHO-5 well-being index: a multiple-choice grid including five questions.
Section 3: FertiQoL questionnaire including 34 items (Likert scale).
Section 4: CSI-4 couple’s satisfaction index: four questions (Likert scale).
Section 5: PDRQ-9 the patient-doctor relationship questionnaire: nine questions (Likert scale).
The standardized questionnaires, which measured, couple’s satisfaction, patient-doctor relationship, underwent a meticulous process of double translation. Initially, they were translated from English to Arabic following the WHO translation guidelines. Subsequently, to ensure linguistic accuracy and cultural relevance, the translated questionnaire was then back translated from Arabic to English.
2.7.1 Description of CSI-4 score
The Couples Satisfaction Index (CSI-4) is a brief self-report questionnaire designed to assess relationship satisfaction within a couple. It's a shorter version of the more comprehensive CSI (Couples Satisfaction Index). Participants were asked to provide their perceptions of their relationships using multiple scales. First, they were asked to rate the level of reward in their relationship and their general satisfaction, using a scale from 0 (indicating no reward or satisfaction) to 5 (indicating complete reward or satisfaction). Additionally, participants assessed their overall happiness in the relationship on a scale ranging from 0 (Extremely Unhappy) to 6 (Perfect). Furthermore, they evaluated the truthfulness of a statement about their relationship on a scale from 'Not at all TRUE' to 'Completely TRUE.' This statement was: 'I have a warm and comfortable relationship with my partner.' The combination of these scales allowed participants to express various aspects of their relationship perceptions, including reward, satisfaction, happiness, and truthfulness. For scoring the CSI-4, respondents' answers to all items are summed. In terms of interpretation, CSI-4 scores have a range of 0 to 21. Higher scores on this scale are indicative of greater relationship satisfaction. On the other hand, CSI-4 scores below 13.5 suggest significant levels of dissatisfaction within the relationship [14].
The research article by Funk and Rogge (2007) validated this scale in English and authorized its use [7]. The Cronbach’s alpha in this study was 0.974. Calculation: Variables were recoded and computed into total score according to the CSI-4 scoring method (attached in appendix 2). The calculation syntax is attached in appendix 6.
2.7.2 Description of WHO-5 score
The WHO-5 Well-Being Index consists of the following five questions:
(1) I have felt cheerful and in good spirits;
(2) I have felt calm and relaxed;
(3) I have felt active and vigorous;
(4) I woke up feeling fresh and rested;
(5) My daily life has been filled with things that interest me.
Considering the score, each of the five questions in the WHO-5 scale is rated on a 6-point Likert scale, ranging from 0 (at no time) to 5 (all of the time). Participants select the response that best reflects their well-being during the last two weeks. The total score on the WHO-5 Well-Being Index is calculated by summing the scores for each of the five questions. The overall score can range from 0 to 25, with higher scores indicating better well-being. In other words, a higher score suggests that the individual has experienced more positive emotions, vitality, and overall well-being in the past two weeks. Conversely, a lower score may indicate a lower level of well-being or potential mental health concerns [15]. A study validated the WHO5 questionnaire within an infertile population and found a Cronbach's alpha of 0.858, indicating good reliability [16]. It has consistently demonstrated strong reliability, with Cronbach's alpha values ranging from 0.991.
Calculation: Variables were recoded and computed into total score according to the WHO-5 scoring method (attached in appendix 3). The calculation syntax is attached in appendix 6.
1.7.3 Description of PDRQ-9 score:
The Patient-Doctor Relationship Questionnaire (PDRQ-9) is composed of nine items, each assessed using a 5-point Likert-type scale, with ratings ranging from 1 (indicating 'not at all appropriate') to 5 (representing 'totally appropriate’) [17]. These items have been thoughtfully designed to evaluate various facets of the doctor-patient relationship, encompassing vital elements such as trust, communication, and satisfaction. The total score is derived by summing the responses to each item. Elevated total scores denote a more positive perception of the doctor-patient relationship, falling within the range of 9 to 45 [18]. It is noteworthy that the reliability of this instrument, as assessed through Cronbach's alpha, demonstrated remarkable internal consistency, with a calculated value of approximately 0.969, signifying a high degree of reliability. Previous research has consistently reported substantial internal consistency, with a Cronbach's alpha of .94, reaffirming its reliability [19]. The PDRQ scale has been effectively utilized for the evaluation of doctor-patient relationships in diverse contexts, spanning patients with physical ailments [20] and those with mental health conditions [21]. It has consistently exhibited exceptional reliability and validity across various cultural settings [21] [22]. Calculation [18] : Variables were recoded and computed into total score according to the calculation syntax attached in appendix 6.
1.7.4 Description of FERTIQOL INTERNATIONAL 2008: scores and subscales
The FertiQoL serves as a valid instrument for evaluating the well-being of individuals facing infertility challenges. It's a self-administered questionnaire created through collaborative efforts by researchers and clinicians from the European Society of Human Reproduction and the American Society of Reproductive Medicine (ASRM). This questionnaire comprises two key components: The Core FertiQoL module and an Optional Treatment Module, as shown in appendix 4. The Core FertiQoL is composed of 24 items, divided into four domains: emotional (measuring the emotional impact of infertility, including feelings of sadness, resentment, and grief), cognitive and physical (exploring how infertility affects physical health, cognitive function, and behavior), relational (evaluating its influence on partnerships), and social (examining its impact on social inclusion, expectations, and support). The Optional Treatment Module of FertiQoL consists of two domains, aimed at assessing the treatment environment and the tolerability of infertility treatment. All items in the FertiQoL questionnaire, whether in the core or optional sections, are rated on a scale from 0 to 4. The scores are then calculated and transformed into a range between 0 and 100. While subscales are computed / 100, fertiQoL score can range from 0 to 120. A higher FertiQoL score indicates a better quality of life, while lower scores suggest a poorer quality of life among individuals experiencing infertility. Importantly, the FertiQoL tool has been translated into over 20 languages, including ARABIC and English. In this particular study, the researchers utilized the officially printed ARABIC/ English translation of FertiQoL, which can be accessed on the FertiQoL website (http://www.fertiqol.org) [23]. It has demonstrated good reliability, with Cronbach’s alpha ranging from 0.949. Calculation: Variables were reversed, recoded and computed into total score according to the FertiQoL scoring method (attached in appendix 5). The calculation syntax is attached in appendix 6.