CTRI201908020997 2019.

Study name	Effect of lifestyle modification and education on information needs and satisfaction level of infertile couples
Methods	Study design: parallel‐group randomised controlled trial Setting: single centre/hospital (India)
Participants	50 couples taking treatment for infertility
Interventions	Control: routine care "Couples will take treatment as usual and recommended by physician apart from lifestyle modification advice" Intervention: combination Group 1: face‐to‐face counselling on lifestyle One‐to‐one/group training through videos, lectures/demonstrations, display of posters, and PowerPoint presentation on lifestyle Group 2: face‐to‐face counselling on lifestyle + self‐instruction manual (SIM) A customised, patient‐centred self‐instruction manual (SIM) to cater to needs of infertile couples developed based on baseline survey and felt needs of respondents. "It includes general information regarding reproductive system, causes of infertility (related to both male and female), various treatment options available, lifestyle modification approaches, psychological aspects, basic information for child adoption etc. Lifestyle changes are the non‐pharmacological approaches for behavior modifications to encourage positive changes in one’s life like eating right or physical activity. Dietary advice includes eating right potion (both quantity and quality) of food which includes all essential nutrients. Diet high in unsaturated fats, whole grains, vegetables, fruits, nuts and fish is advised. Limit intake caffeine, smoking, alcohol consumption, high glycemic index foods etc. Physical activity should be made part of daily life. Exercise of minimum 30 minutes is advised each day. Apart from this Yoga and meditation is also advised to couples"
Outcomes	Quality of life (measured with FertiQOL = primary outcome) and conception rate defined as the number of infertile women who get pregnant spontaneously or from ART during the study time period
Starting date	January 2020
Contact information	drdavinderkaur89@gmail.com (PhD); dramarjeet56@gmail.com (PI)
Notes	Status of study: ongoing: study authors replied by email 28 January 2021 that trial was still ongoing, and that no data are available that can be included in this review at this point. Estimated study completion date is after 1 year Other notes: additional information on intervention and definition of pregnancy would be valuable when study will be included