Design, implementation, and evaluation of an electronic support intervention versus usual care on improving the reproductive health of couples undergoing infertility treatment and investigating the effect of this intervention on the response to treatment:a randomized clinical trial

Evaluating the effect of electronic intervention on the reproductive health of infertile couples and the response to treatment

Random and controlled clinical trial, one-blind with 100 samples

The study will be place at the infertility department of Bahar Hospital, in Shahroud, Semnan Province. The participants will be infertile couples who seek treatment at this center. Blinding will be conducted by statistician who will provide a block list to an individual not involved in the study. This person will then prepare envelopes that contain the names of either the intervention or control group following the order of the list and number them accordingly. The envelopes will be handed over to the person in charge of the infertility department. Once informed consent is obtained from the infertile couple, the first envelope sealed from the numbered box which is provided by the infertility department official will be given to the principal investigator.

Entry criteria: Couples with primary or secondary infertility, Non-entry criteria: Participation in other educational classes and having a mental illness .

The participants of the intervention group are invited to attend training classes during their first visit to the infertility center toopen their case. The number of meetings, timings andinstructions on how to participate in the classes are explained both verbally and in writing. Educational videos are uploaded on the infertility center's website and couples are provided with these videos according to predetermined schedule. The control group only receives routine care provided by the center..

Reproductive health, response to treatment

The random allocation of couples is conducted using a block of four and by a computer randomization administered by a statistician. A table is generated from this allocation and envelopes are prepared by an individual who is not involved in this research. These envelopes are numbered sequentially and contain either the intervention or control type. The thick envelopes, arranged in the specified order, are then placed in a box. The responsibility for admitting participants to the infertility section, which is not involved in the research, lies with someone else. Once participants provide their consent to participant in the study, the admission officer of the infertility center will open the envelope and allocate participant to the designated group. Participants will remain unaware of the group allocation.

All participants (infertile couples) in the control and intervention groups will receive routine care, however the intervention group will also receive electronic counseling through educational videos posted on the infertility center website. These videos will have their educational content reviewed and approved by professors in this field. Participants in the control group will only receive usual care. Both groups will be unaware of this allocation. Clinical caregivers will perform all routine tasks for both groups without being notified. The person responsible for data collection is a research assistant who will complete the questionnaires over the phone or in person for both groups. The research assistant who analyzes the data from the questionnaires will also be unaware of the assigned groups.

After publishing the article and anonymizing the participants, the data file can be sent via email as requested

After publishing the research paper of the project for 6 months

For all Academic Researcher

An approved proposal whose goals indicate the need for this information

By Email

After the approval of the project partners, the information will be sent within three weeks