Reproductive Risk Factors Associated with Female Infertility in Sonepat District of Haryana: A Community Based Cross-Sectional Study.

Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. Primary infertility is the inability to have any pregnancy, while secondary infertility is the inability to have a pregnancy after previously successful conception. [ 1 ] In 2004, the World Health Organization's (WHO) first global strategy on reproductive health was presented. [ 2 ] Infertility is a global reproductive health problem, and the prevalence rate has increased by 0.37% per year for females resulting in the global disease burden of infertility steadily increasing from 1990 to 2017. [ 3 ] The WHO estimates of primary infertility in India are 3.9% (age-standardised to 25–49 years) and 16.8% (age-standardised to 15–49 years). As per a study, published at the end of 2012 by the WHO, one in every four couples in developing countries had been found to be affected by infertility. [ 4 ] In India, district-level household survey 3 reported an 8.2% prevalence of infertility amongst women, of which 6.3% is primary while 1.9% is secondary. [ 5 ] There are many causes of infertility such as ovulatory factors, utero-tubal peritoneal factor, infection, lifestyle factors, advancing maternal age, postponement in childbearing and occupational hazards. [ 6 , 7 ] Sexually transmitted infections (STIs) are generally considered the leading preventable cause of infertility worldwide, especially in developing countries. [ 8 ] Infertility can have a serious impact on both the psychological well-being and the social status of women in the developing world. This becomes particularly traumatic with previous pregnancies that end in miscarriages, stillbirths and neonatal/infant deaths. [ 4 ] Many of the risk factors for infertility are avoidable. Thus, considering the importance of fertility, we conducted this community-based cross-sectional study with the aim to find out the prevalence of infertility and its association with reproductive risk factors amongst women of reproductive age group (18–49 years) in district Sonepat, Haryana.

The prevalence of infertility is shown in Figures 1 and 2 . Out of 444 study participants, majority of women were fertile (88.7%), while 6.3% of women had secondary infertility followed by 5% of women who had primary infertility. Participants were equally chosen from rural and urban areas. The prevalence of infertility was more common in the rural area (12.6%) as compared to the urban area (9.9%), but the difference was not statistically significant ( P = 0.368). Majority of the study population were in the age group of 30–39 years, followed by 20–29 years. Flow chart showing the sampling technique of the study. * Selected by simple random sampling technique Distribution of study population by fertility status ( n = 444) About three-fourth of the study participants had their menarche at age more than 13 years. The mean age of menarche for the participants of the fertile group was 14.36 years (SD = 1.38) and for the infertile group was 14.34 years (SD = 1.40). The prevalence of infertility was 38.7% amongst those who had their menstrual cycle duration of more than 50 days followed by 15.7% infertility amongst those who had their menstrual cycle duration of 18–25 days. Majority of study participants had an average amount of menstrual flow. Infertility was 16.9% amongst those who had a heavy amount of menstrual flow as compared to 8.8% who had a normal amount of menstrual flow. More than half of the study participants never had a history of pre-menstrual symptoms. 15.6% of the study participants who had a history of pre-menstrual symptoms sometimes were infertile as compared to 9.6% of participants who never had a history of pre-menstrual symptoms. The difference of occurrence of infertility in relation to menstrual cycle duration ( P ≤ 0.001) and menstrual flow amount ( P = 0.048) was statistically significant [ Table 1 ]. Distribution of study population according to menstrual history *Statistically significant Most of the participants had no intermenstrual bleeding. The prevalence of infertility was 14.6% in those who had intermenstrual bleeding as compared to 10.9% in those who had no intermenstrual bleeding. The prevalence of infertility was 20.3% in those who had irregular menstrual cycle as compared to 8% in those with regular menstrual cycle ( P ≤ 0.001). More than half of the participants had no history of dysmenorrhea. 18.7% of study participants who had a history of dysmenorrhea were infertile as compared to 7.5% of participants who had a history of dysmenorrhea ( P ≤ 0.001). Majority of women were not used to take medicines to start periods. The prevalence of infertility was 37.5% in those who were not used to take medicines to start periods as compared to 10.3% in those who usually took medicines to start periods ( P = 0.001) [ Table 2 ]. Distribution of study population according to problems associated with menstrual cycle *Statistically significant Table 3 shows that all the symptoms of reproductive tract infection (RTI)/STI were more common amongst infertile study participants. The most common symptoms of RTI/STI were genital discharge, lower backache, itching and reddening. The difference of occurrence of infertility in relation to genital discharge ( P = 0.049), genital ulcer/sores ( P ≤ 0.001), groin swelling ( P ≤ 0.001) and warts ( P = 0.015) was statistically significant. Distribution of study population according to symptoms of respiratory tract infection/sexually transmitted infection *Statistically significant

A considerable percentage of women experience the problem of infertility in district Sonepat, Haryana. This study revealed significant potential determinants of infertility amongst the subject under study, indicating the existence of a positive relationship between genital discharge, genital ulcer/sores, groin swelling, warts and their infertility issues. We recommend focusing on programmes aiming at the reduction of the prevalence of STIs which are significant risk factors for infertility. Intergration of STI programmes with other reproductive health programmes such as RMNCH, ARSH etc. and by providing these services with sufficient laboratory resources, competent labor, treatment, and counseling services, we can identify disorders early. Teenage girls could very well benefit from earlier education on variables like PCOD that can be changed, allowing them to more effectively plan their future. Regular health examinations, stress management, encouragement of a healthy lifestyle to maintain a normal BMI, including adherence to a nourishing food and regular exercise should be encouraged. Nil. There are no conflicts of interest. The data used in this study are available with the corresponding author who is willing to share it upon reasonable request.

The prevalence of infertility has increased significantly in recent years, As per the WHO, the overall pooled lifetime prevalence of infertility was 17.5%, and the overall pooled period prevalence of infertility was 12.6%. [ 9 ] In the present study, of 444 women of reproductive age group, 22 (5%) had primary infertility while 28 (6.3%) had secondary infertility. Hence, the prevalence of infertility is 11.3% in women of reproductive age group (18–49 years) in XXXX district of XXXX which was well comparable to the global data. However, it was less than some countries, for example, Canada (15.6%), [ 10 ] China (14.2%) [ 11 ] and Iran (21.1%), [ 12 ] which may be due to different sociocultural factors in those countries. Studies conducted in India by Kumar [ 13 ] and Mittal et al . [ 8 ] reported infertility rate of 14.2% and 11.98%, respectively, which is well comparable to the results of our study. In another study by Kaur et al . [ 14 ] in Rajasthan, out of total 1000 women studied, 119 (11.9%) were found infertile. In our study, the prevalence of infertility was more in the rural area (12.6%) as compared to the urban area (9.9%) which was concordant with the results of Mokhtar et al . [ 15 ] who reported more infertility in rural areas. Investigators encountered a problem where persons had a tendency to conceal their infertility status, which may be one explanation for the less frequently reported prevalence of infertility in urban areas. Another explanation may be the fact that medical services continue to be lagged behind in these rural areas, self-care for women was relatively poor, therefore women were more prone to suffer from the infertility. In contrast to this, Kaur et al ., [ 14 ] NFHS 2 [ 16 ] and NFHS 3 [ 17 ] reported that the infertility rate is higher amongst women in urban areas. DLHS 3 of XXXX (2007–08) reported that women who had primary or secondary infertility constitute 11.1% of ever-married women of reproductive age group, from which 10.6% of women belonged to the rural area while 12.5% of women belonged to the urban area. Thus, the prevalence of infertility varies between countries and in between the different parts of the same country. In our study, 13.2% of infertile females had their menarche age 13 years while only 10.5% of infertile females who had their menarche age above 13 years. An early age at the first menstruation increases the incidence of disease such as pelvic inflammatory disease that can cause infertility and spontaneous abortion at later ages. In our study, there was no significant relationship between the age of the first menstruation and the prevalence of infertility. Similar results have been reported in the study of Adamson et al . [ 18 ] and Gokler et al . [ 19 ] In the present study, it was observed that any form of menstrual irregularity in the form of any deviation from normality like menorrhagia, hypomenorrhoea and menstrual cycle duration less or more than normal was significantly associated with infertility. The results of studies done by Manna et al ., [ 20 ] Shamila and Sasikala [ 21 ] and Mittal et al . [ 8 ] also reported that oligomenorrhoea and hypomenorrhoea have a positive association with infertility. A study conducted by Dhont et al . [ 22 ] also supports our study. In this study, it was observed that 14% of infertile women were using home cloth during menstruation as compared to 10.9% of infertile women who were using sanitary napkin/pad. Menstrual hygiene plays an important role in infertility. Unhygienic menstrual practices such as reusing cotton clothes, washing them without soap and with unclean water, social taboos and restrictions force drying indoors, away from sunlight and open-air predispose these women to lower RTIs, and ultimately infertility. A study conducted by Katole and Saoji [ 7 ] in 2019 in urban population of India also had results concordance with our study. It was observed in our study that 18.7% of infertile women had history of dysmenorrhea as compared to only 7.5% of infertile women who had no history of dysmenorrhea. Dysmenorrhea is an important finding for many diseases such as polycystic ovary syndrome and endometriosis which are known to cause infertility. Studies done by Mittal et al ., [ 8 ] Speroff et al . [ 23 ] and Gomathi et al . [ 24 ] had similar results. However, another study conducted by Gokler et al . [ 19 ] found no difference in the prevalence of infertility amongst women with and without a history of dysmenorrhea. This might be resulted from the small number of women in the study with a history of dysmenorrhea. In our study, all RTI/STI symptoms were more prevalent in infertile women than in fertile women, and the symptoms that were strongly linked to infertility were genital discharge, genital ulcers or sores, groin swelling, and warts The rest of the symptoms such as lower abdominal pain, burning micturition, lower backache, itching, reddening and skin rashes were also more prevalent in the infertile females but not statistically significant association with infertility. The findings of our study were concordant with the results of studies done by Adamson et al ., [ 18 ] Mittal et al ., [ 8 ] Manna et al ., [ 20 ] Cong et al . [ 25 ] and Safarinejad. [ 26 ] Amongst women in our study, unprotected sex by infertile couples was significantly associated with infertility, possibly by increasing the likelihood of contracting a STI/RTI from their partner. However, it may also be possible that couples without children may be actively trying to conceive by increasing the number of unprotected sexual acts, which may account for this association. STIs (irrespective of the causative agents) or their sequelae such as tubal fibrosis and obstruction were extensively studied and proved in developed as well as in developing countries. In this study, the estimation of prevalence of infertility was based on questionnaire-based interview method. Despite extensive data seeking, the current study relied on women's response to these questionnaires; these assumptions may be inaccurate, as women may not reveal accurately on this sensitive topic. It only includes causes of infertility related to women; issues related to men in detail were neglected. As the current study was conducted entirely within Sonipat district, hence the results cannot be generalised.

This observational cross-sectional study was conducted amongst the reproductive age group women who were residents of district Sonepat, Haryana. The study was conducted in district Sonepat, Haryana, which is one of the 22 districts in Sonepat, Haryana, located in the northern zone of the country. The period of recruitment of study participants was between August 2021 and May 2022. Married reproductive age group (18–49 years) women who were residents of district in Sonepat, Haryana for at least 6 months were enrolled. Inclusion criteria: Those who gave written consent were included in the study. Those who gave written consent were included in the study. Exclusion criteria: Separated/divorced women Married women with marriage duration <12 months Menopausal (natural/artificial) women Those with any debilitating medical or related condition like mental illness (dementia or psychotic illness), end-stage cancer and blindness rendering them unable to be interviewed were excluded from the study. Separated/divorced women Married women with marriage duration <12 months Menopausal (natural/artificial) women Those with any debilitating medical or related condition like mental illness (dementia or psychotic illness), end-stage cancer and blindness rendering them unable to be interviewed were excluded from the study. The calculated sample size was collected equally from urban and rural areas of district in Sonepat, Haryana. For rural area sampling, one community health centre (CHC) was selected by simple random sampling. From the selected CHC, two primary health centres (PHCs) were selected randomly. For urban area sampling, two urban health centres (UHCs) were selected randomly from urban area of district in Sonepat, Haryana. One sub-centre from each PHC and one urban sub-centre from each UHC were selected randomly. A sampling frame containing a list of all reproductive age group women (18–49 years) was obtained from multi-purpose health worker (MPHW) (F) of the selected area. The study participants from the sampling frame were chosen randomly by the investigator herself. The sample size was estimated on the basis of reference studies which reported the prevalence of infertility to be 11.8%, [ 8 ] with 3% absolute precision at 95% confidence interval. The sample size was calculated using the following formula: n = ([ Z 2 × P × q ]/L 2 ), where n = sample size, Z = 1.96 (95% confidence interval), P = prevalence, q = 1 − P and L = absolute precision. Hence, the total calculated sample size was 444 reproductive age group women. A semi-structured schedule was used after doing necessary modification based on a pilot study which was done on 40 study subjects (10% of the sample size) from a neighbouring district. The variables of the semi-structured schedule were finalised based on their coefficiency of reliability calculated using Cronbach's alpha, whose scores were 0.80. The house visit was carried out during the time of the day when all household members are expected to be available. If an eligible candidate who was not found at home during at least 3 successive visits of investigator, then adjacent household was selected. After explaining the purpose of the study and taking informed written consent from the participant, a semi-structured schedule was used by the investigator through face-to-face interviews to collect information about general characteristics and sociodemographic profile, relevant medical, menstrual and gynaecological history. Interviews were conducted in the local language. The primary focus was on quality of data collection. An attempt to minimise recall bias, associated with timing of a particular event, was made by asking questions about the related important events in the respondent's life; for example, information about age at menarche was not remembered correctly by some of the respondents; in these cases, respondents’ information was deduced by correlating age of menarche with any important event in past. Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. Primary infertility is the inability to have any pregnancy, while secondary infertility is the inability to have a pregnancy after previously successful conception. The collected data were entered into a Microsoft Excel spreadsheet. Mean and standard deviation (SD) were calculated for quantitative data. Percentages and proportions were calculated for qualitative data. The categorical data were analysed statistically using Chi-square test and odds ratio with 95% confidence interval. Continuous variables were analysed using independent t -test. All the analysis was done using R software was created by Ross Ihaka and Robert Gentleman at the University of Auckland, New Zealand. P <0.05 was considered statistically significant. The ethical clearance for the study was taken from the Institutional Ethics Committee of Bhagat Phool singh Government Medical College for Women. Due approvals were also obtained from the Scientific Committee and University Ethics Committee (Approval number: BPSGMCW / RC 633 / IEC / 2021). The study adhered to the principles of the Helsinki Declaration (2013).