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IRCT20100701004281N4 IRCT 2023-11-11 Shahroud University of Medical Sciences The effect of an electronic intervention on the reproductive health and response to treatment in infertile couples 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 2023-11-01 anticipated 100 Complete https://irct.ir/trial/73423 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: A single_ blind clinical trial, with a parallel control group. The randomization process will be carried out using computer program resulting 100 participants with 50 assigned to the intervention group and 50 to the control group, Randomization description: 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, Blinding description: 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. N/A Infertility. Control group: usual care provided infertility ward. Yes - There is a plan to make this available What will be shared: After publishing the article and anonymizing the participants, the data file can be sent via email as requested When: After publishing the research paper of the project for 6 months To whom: For all Academic Researcher Conditions: An approved proposal whose goals indicate the need for this information Where to obtain: By Email How to obtain: After the approval of the project partners, the information will be sent within three weeks Comments:
public Azam Hamidzadeh
7th Tir square, Tehran street
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 5054 Azhamidzadeh@shmu.ac.ir Shahroud University of Medical Sciences scientific Shahrbanoo Salehin
7th Tir square, Tehran street
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 5054 drbsalehin@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) A Diagnosis of infertility or a history of unsuccessful attempts to conceive for twelve months or more, primary or secondary infertility, absence of living children in secondary infertility, absence of adopted children, ability to read and write, residents of Shahroud city, couples receiving assisted reproductive methods For the first time, the agreement of both couples to participate in the study, having a smart phone or computer that receives the educational program or text messages and mastering its use at home, work, etc., having informed consent to participate in the study, lack of Any physical or mental illness in the couple, willing to participate in the research 21 years 45 years Both Having psychological diseases, a history of psychological diseases, taking psychiatric drugs or participating in other psychological interventions during the treatment stages such as (IVF...), experiencing a stressful or unfortunate event in the last 6 months and engaging in smoking, alcohol or consumption, or drugs use in couples. Male and F N97.4 N/A Control group: usual care provided infertility ward Improving Reproductive Health. Timepoint: Before intervention, after completion of counseling sessions. Method of measurement: Reproductive Health Questionnaire. Infertility stressB. Timepoint: Before the intervention - after the counseling sessions. Method of measurement: Using the Infertility Stress Questionnaire. Life Style. Timepoint: Before the intervention - after the counseling sessions. Method of measurement: Using the Walker's Health Promotion Lifestyle Questionnaire. The scores of the dimensions of the sexual self-concept. Timepoint: Before the intervention - after the counseling sessions. Method of measurement: Using the Snell Sexual Self-Concept Questionnaire. Drug Compliance (MARS's 10-item questionnaire) was conducted to measure drug compliance, the grading rate was never = 5, rarely = 4, sometimes = 3, most often = 2, always = 1. The scores obtained from this The questionnaire is divided into 10, and thus the range of scores to be obtained in a questionnaire is from 1 to 5. A score of more than 4.5 indicates good drug compliance and a score of less than 4.5 indicates poor drug compliance.). Timepoint: Before the intervention - after the counseling sessions. Method of measurement: Using questionnaire Medication Adherence (MARS). Ovarian follicle size. Timepoint: Before the intervention and during 10th to 12th of menstrual cycle (in case of lack of proper size of the ultrasound follicle on days 14-16 and finally 20-22 cycles) after the intervention. Method of measurement: vaginal ultrasound. Numbers of dominant follicles. Timepoint: Before the intervention and during 10th to 12th of menstrual cycle (in case of lack of proper size of the ultrasound follicle on days 14-16 and finally 20-22 cycles) after the intervention. Method of measurement: vaginal ultrasound. Implantation Rate. Timepoint: Two weeks after the assisted reproductive procedure. Method of measurement: Serum BhCG level. Shahroud University of Medical Sciences Approved 2023-11-06 Ethics committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Taheri Ave Shahroud Semnan Iran (Islamic Republic of)