Type and setting of study
This was a cross-sectional study with an analytical focus for a period of 6 months (18 June to 18 November 2021) conducted among women of childbearing age (15 to 49 years) in the Conakry city in 2021.
The Conakry city is the capital of the Republic of Guinea. It is the country's largest demographic agglomeration with nearly 2,039,725 inhabitants in 2021(21). Overall, the total fertility rate in Guinea is 4.8 children per woman. The socio-economic situation in Guinea is marked by persistent poverty. According to recent statistics from the ‘’Institut National de la Statistique (INS)’’, the national poverty rate is 43.7%, meaning that 43.7% of the Guinean population lives below the poverty line. A large proportion of this population lives in vulnerable areas, notably in urban slums and in rural areas (21). In addition to the high maternal mortality rate and low health service coverage, the country is facing the emergence and re-emergence of epidemic diseases, including Ebola (2014 - 2016, and again in 2021), Marburg Haemorrhagic Fever in 2021, etc. (22).
In Guinea, the management of infertility consists mainly of clinical and Para clinical investigations to ensure that it is infertility and to identify the cause; then follows the treatment of the causes. In the event of failure to treat, a referral is made to a higher level health structure (23). To our knowledge, apart from these practitioners' recommendations, no national protocol and no formal national strategy for the prevention and management (medical and psychosocial) of infertility exist in Guinea.
Study population
Women meeting the following criteria were included in the study: i). aged 15-49 years; ii). living in a couple (married or cohabiting) for 12 months or more; iii). having, at some point, regular unprotected sex with a desire for pregnancy for at least a period of 12 months; and iv). residing locally in one of the five communes of the city of Conakry for at least 3 months prior to data collection. The exclusion criteria for participants were: i). single women of reproductive age; ii). women of reproductive age who had not given informed consent for participation in the study.
Sampling and data collection
The sample size was calculated by the SCHWARTZ formula (n= (〖eZα〗^2 × pq)/i^2); where n= sample size, e = cluster effect equal to 2.3; p = expected prevalence of infertility, estimated at 50% (chosen because there is no previous reference study in Guinea), q = 1-p, Zα = the standard deviation constant, equal to 1.96 corresponding to the 5% risk of error and i = desired precision of the estimate, set at 5%. The non-response or wrong answer rate was set at 10%. Thus the number of women to be interviewed in each of the five communes was 972.
A three-stage cluster sample was used to select targets in each of the five municipalities of Conakry city. The first stage consisted of the selection of sectors. From the list of sectors, a random selection of 30 sectors was made per municipality. An automatic random number generator (Open Epi) was used to select the survey sectors. The second stage was the selection of households. Thus, starting from a crossroads in the centre of each sector, the interviewers turned a pen and threw it in the air. The direction was indicated by the tip of the pen. Following this direction, they proceeded to select the households. The first household on the right was the first to be visited. When there were no interviewees, the one on the opposite side was selected. Then the interviewers proceeded in a stepwise fashion until they had enough people to interview in each cluster. The number of households per cluster was obtained by dividing the sample size by the number of clusters. The third stage was the selection of women in households. In the households, the women to be interviewed were selected according to the eligibility criteria. If there were no eligible women in the household, the interviewers continued to the next household in the direction indicated by the pen. The survey was conducted when informed consent was obtained. If the woman refused to participate in the survey, the interviewers clearly emphasized the purpose and importance of the study. If she persisted, the interviewers moved on to the next household. If the area was crossed before the expected number of women to be interviewed was reached, the interviewers returned to the center of the municipality and repeated the same technique in the opposite direction until the desired number of women was reached.
Data were collected through the administration of a semi-structured questionnaire. Data collection was carried out by final-year medical students at the Gamal Abdel Nasser University in Conakry. These students were trained for three days on the objectives of the research, unfamiliar medical terminology, and the administration of the questionnaire in French and in the main local languages of the country (Fulani, Malinke, Soussou, Kissi, Kpèlè and Toma). The questionnaire was deployed in the Kobo collect v1.14.0 application to facilitate its administration.
Study’s variables
a) Prevalence variables and factors associated with infertility
The dependent variable in this study was infertility, both in its primary and secondary forms and in its general form. In this study, infertility was defined as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sex (24,25).
Primary infertility was defined as a woman who had never been diagnosed with a clinical pregnancy and who met the criteria for classification of infertility; whereas secondary infertility was defined as a woman unable to establish a clinical pregnancy who had already been diagnosed with a clinical pregnancy (26).
The question about the experience of infertility was asked of all participants included in this study. The question was: "Have you ever had a time, lasting 12 months or more, when you and your partner tried to get pregnant, but it didn't happen? We considered a participant to be infertile when she answered "yes" to this question (27).
To classify women with infertility into primary and secondary infertility, we asked the following question: "Have you ever had a pregnancy that was completed and/or resulted in a live birth? We considered a woman to have primary infertility if she answered "No" to this question; and women who answered "Yes" to this question were considered to have secondary infertility.
The independent or explanatory variables of infertility were composed of socio-demographic characteristics (age, education level, religion, ethnicity, marital status, social conditions, occupation, lifestyle, etc.); and clinical characteristics (gynaecological history, medical history, surgical history, etc.).
b) Variables related to the psychosocial consequences of infertility
The variables related to the psychosocial consequences of infertility were made up of variables defined in the General Health Questionnaire - 28 (GHQ-28), which includes 28 items (28). The GHQ-28 is a standard questionnaire that is used as a tool to assess psychological well-being. It was chosen as the primary endpoint based on the results of a comparable trial and because it was evaluated as an appropriate tool to capture emotional stress. The GHQ-28 asks participants to indicate the state of their general health in recent weeks, using behavioural items with a 4-point scale indicating the following frequencies of experience: "not at all", "no more than usual", "rather more than usual" and "much more than usual".
Analysis of the data
a) Analysis of prevalence and factors associated with infertility
In the descriptive analysis, all quantitative variables were expressed as medians with interquartile ranges and as means with their standard deviations. Categorical variables such as type of infertility and etiological factors were expressed as percentages.
Univariate and multivariate analyses were performed to investigate associations between infertility and explanatory variables. In the univariate analysis, the crude odd ratio was used as a measure of association with 95% confidence intervals and p-value. Covariates for multivariate logistic regression were selected if the p-value was less than or equal to 0.20 in univariate. The adjusted odd ratio was calculated to identify non-confounding associations between infertility and explanatory variables. We adjusted simultaneously for several variables in the models. The associations observed in this study were not due to confounding by any of the other variables in the models. A p-value <0.05 was considered statistically significant.
b) Analysis of the psychosocial consequences of infertility
A descriptive analysis was carried out using the GHQ-28 to study the psychosocial consequences of infertility among the victims. To assess the general health of the victims, we used the original scoring system, the Likert scale 0, 1, 2, 3. The minimum score for version 28 is 0 and the maximum is 84. Higher GHQ-28 scores indicate higher levels of distress. Goldberg suggests that participants with total scores of 23 or less should be classified as non-psychiatric; whereas participants with scores > 24 can be classified as psychiatric; but this score is not an absolute cut-off. It is recommended that each researcher derive a cut-off score based on the average of their respective sample (28). The assessment of psychological impact (psychological damage) in infertility victims was also carried out. A woman was considered psychologically impaired when she had at least one of the following problems: anxiety, depression, somatisation, social dysfunction. This was established through interpretation according to ''The Hospital Anxiety and Depression Scale (HADS)'', where a score ≤ 7 means there is no impairment; a score of 8-10 reflects doubtful symptomatology and a score of 10 ≤ reflects definite symptomatology (29).
Ethical considerations
The study had no risk of adverse effects as it was non-interventional. However, before the launch of this study, the research protocol was presented for validation and approval to the scientific committee of the public health chair of the Faculty of Health Sciences and Technique of the Gamal Abdel Nasser University of Conakry. The study protocol was registered at the University of Conakry under number 638/B/DC/FSTS/VDR/UGANC/RECT. Oral and written informed consent was obtained from each participant before the questionnaire was administered. In order to preserve confidentiality, the data collected was made anonymous. It was only accessible to the investigators.