Objective: To compare the impact of two educational intervention strategies on physical, mental and social health of infertile couples at OBG – OPD at PGIMER with those receiving routine care.

Study design – 3 group parallel designs RCT with allocation ratio as 1:1.

Participants– Infertile couples reporting at OBG OPD of PGIMER

Intervention – Face to face counseling + SIM (Self Instructional Module)

Comparator –        

a)    Face to face counseling only.

b)    Routine care (no additional intervention)

Outcome Variables–

·         Score of mental health of infertile couple

·         Score of quality of life.

·         Conception rate.

Null Hypothesis: H₀: There will be no difference in the scores of physical, mental and social health of 3 groups of infertile cases reporting at OBG OPD of PGIMER at the endline.

Alternate Hypothesis: H₁: There will be a definite difference in the scores of physical, mental and social health of infertile cases reporting at OBG OPD of PGIMER at the endline.

Sampling method and sample size –

In this intervention study, selected eligible infertile cases seen in gynaecology OPD during study period will be randomized into three groups for randomized control trial (RCT) with a  sample size of 55 patients. Sample size formula: N=C*(p1q1+p2q2) / (p1-p2)2 Where, C=7.8 (for the power of 80% & alpha 5%), N=sample size in one arm, p1=0.3, p2=0.6, q=1-p

N = 36 (enhanced to 50 with margin for drop out)

It is assumed that face to face counseling and SIM will improve information needs of patients by 60% and face to face counseling alone will improve information needs of patients by 30% in the post intervention period.

Randomization Process:

Randomization will be done by faculty not involved in the study to allocate the patients in 3 groups i.e. A, B & C. Group C patients will be controls. Stratified block randomization will be used. Block size will be taken as three. Six possible sequences will be generated (ABC, CAB, ACB, CBA, BCA, BAC). Random number tables will be used to allocate patient to a particular sequence.

Once a patient is diagnosed with infertility she will be referred by the doctor to researcher’s room for group A & B patients recruitment (room no. 2060 of Gynaecology OPD) after clinical work up and necessary investigation/prescription. Here the patient will be randomly allocated to an intervention/comparator group and counseled accordingly. Patients for control group i.e. group C will be allocated at the infertility clinic. Nothing beyond routine care will be provided to them. No blinding will be done in this study.

Follow Up –                                                                                                                                      

All the patients will be followed up at one, three and six months after recruitment at OBG OPD. Patients will be reminded beforehand regarding the date of their follow up. If a patient is not visiting on the due date, these patients will be reminded to come for follow up in the next OPD. If they do not come then, phone based follow up will be done.

All the patients will be asked to maintain a diary showing the record of performance of self-care activities and adherence to the advice given. On follow up visit, their knowledge level will be checked by the researcher and outcome variables will be evaluated.

Development and Validation of SIM

The SIM used in this study will be developed through:

·         Review of literature regarding infertility, their treatment and side effects.

·         Gathering information on problems faced and information needs of patients and their partner through pilot surveys.

SIM will be individualized, according to the needs of infertile couples. It will be distributed amongst experts for face validity, content validity. After the judging panel validates the SIM, an assessment amongst patients will be done for construct validity.

Five judges will participate in the validation process (doctors with experience in the following areas of care, teaching and/or research: Obstetrics and Gynaecology, public health and nursing). They will be provided with the following: a formal invitation, tool for profile of the judge, informed consent form, study protocol and SIM. A sample of patients (n=10) not recruited for the study will be given the SIM for content validation in terms of understanding of the exhibited material. The validation process will be conducted until no new recommendations for changes are made.

SIM will be adapted to suit the Indian scenario. English, Hindi and Punjabi versions of the SIM will be prepared. At the outset, researcher will undergo an orientation training regarding functioning of OBG OPD. 

Analysis – Analysis will be done using SPSS package. Percentages, mean, SD and paired t test or ANOVA; inter and intra group comparison will be done using parametric and non-parametric statistical tests. Intention to treat analysis will be used. Baseline to end-line comparison will be done.

Ethical aspects – Clearance will be obtained from the ethics committee of PGIMER for the thesis. There will be no interference with the current management of the patients. Written informed consent will be taken from all the respondents as well as the concerned authorities. All data will be kept confidential. The RCT will be registered in ICMR/National Clinical Trial Register.

This RCT does not involve any invasive procedure. It only gives educational interventions. Therefore, there is no likelihood of any harm to patients in either of the three intervention groups. Any adverse event will be reported to Institutional Ethics Committee and trial monitoring committee.