]>
IRCT20181207041873N5 IRCT 2025-11-26 Iran University of Medical Sciences The effect of training based on spouse's support on anxiety, perceived social support, and infertility treatment outcomes in women undergoing assisted reproductive technology Investigating the effect of training based on spouse's support on anxiety, perceived social support, and infertility treatment outcomes in women undergoing assisted reproductive technology 2025-12-06 anticipated 86 Complete https://irct.ir/trial/85349 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible individuals are continuously enrolled in the study and then randomly assigned to the experimental and control groups using blocks of four. The randomisation list is generated randomly online via https://www.sealedenvelope.com (a website for generating block randomisation sequences) in a one-to-one ratio by an individual outside the research team. N/A Female infertility. Intervention 1: The intervention is designed to train husbands of infertile women undergoing IVF/ICSI treatment so that infertile women will be supported by their trained husbands when they begin the treatment cycle. For this purpose, the training of the husbands of the intervention group will be completed before the start of the treatment cycle of infertile women. The training will be conducted virtually by the researcher in 4 sessions of 30-45 minutes by sending educational videos on WhatsApp messenger, with the time interval between sending educational videos being every 5 days. The content of the training sessions for the husbands of the intervention group is as follows: First session: Introduction to the female reproductive system and natural fertilization, introduction to IVF and ICSI and reasons for use, drug preparation, ultrasound and egg retrieval, the husband's supportive role in these stages. Second session: Anxiety during treatment and the problems caused by it, simple anxiety reduction techniques, basic support skills to reduce women's anxiety, extensive social support (family and friends). Session 3: The importance of adequate sleep and the role of the husband in providing a comfortable environment for sleep, healthy nutrition and helping the wife in preparing and choosing the right food, light exercise and encouraging women to move with their husbands, husbands avoiding unhealthy behaviors, husbands taking care of themselves so that they can support women. Session 4: The concept of empathy and examples of it in the treatment process, active listening and examples of it in the treatment process, asking about women's thoughts and feelings, effective companionship methods during treatment, strategies for improving communication and emotional bonding. Infertile women in the intervention group will be supported by their trained husbands during the treatment cycle. The intervention group will also receive routine infertility center consultations from the treatment team, which will include explanations about the fertility treatment method and how to use infertility drugs and their side effects. Finally, they will complete two questionnaires on perceived social support and a state anxiety questionnaire on the day of egg retrieval, while waiting for their turn to undergo the egg retrieval procedure. The number and quality of embryos will also be determined on the third or fifth day after in vitro fertilization using a microscope and based on the embryologist's agreed guidelines. Intervention 2: Control group: The control group will receive routine infertility center consultations from the treatment team, which include explanations about the fertility treatment method and how to use infertility drugs and its side effects. Like the intervention group, they will complete two perceived social support questionnaires and a state anxiety questionnaire on the day of egg retrieval, while waiting for their turn to undergo the egg retrieval procedure. The number and quality of embryos will also be determined on the third or fifth day after in vitro fertilization using a microscope and based on guidelines agreed upon by the embryologist. Yes - There is a plan to make this available What will be shared: Only part of the information, such as information on the main outcome or the like, can be shared When: Start the access period 6 months after publishing the results To whom: Data for researchers and people who are engaged in treatment can apply for them Conditions: Data for researchers and people who are engaged in treatment can apply for them Where to obtain: by Email maryammoradi1478@gmail.com How to obtain: by Email maryammoradi1478@gmail.com Comments:
public Seyede Batool Hasanpoor-Azghady
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 2288 5394 hasanpoor.sb@iums.ac.ir Iran University of Medical Sciences scientific Seyede Batool Hasanpoor-Azghady
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 2288 5394 hasanpoor.sb@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iranian nationality of the couple Having at least three weeks until the start of the IVF or ICSI treatment protocol Having at least some literacy Access to a smartphone and the internet by the infertile woman's husband Couples living together Having primary or secondary infertility(secondary infertility with no history of live birth) no limit no limit Female Having any chronic physical illness such as diabetes, high blood pressure Having mental illness in either partner, according to their report Taking medications that affect the nervous system or psychotropic drugs by a couple Having adopted children Having children with secondary infertility Intention to use donated oocytes Intention to use frozen eggs Intention to use a surrogacy Sex selection using IVF Each partner undergoing psychological counselling Education in psychology and counselling Intense arguments during the week leading up to the start of the study N97 Female infertility Lifestyle N/A The intervention is designed to train husbands of infertile women undergoing IVF/ICSI treatment so that infertile women will be supported by their trained husbands when they begin the treatment cycle. For this purpose, the training of the husbands of the intervention group will be completed before the start of the treatment cycle of infertile women. The training will be conducted virtually by the researcher in 4 sessions of 30-45 minutes by sending educational videos on WhatsApp messenger, with the time interval between sending educational videos being every 5 days. The content of the training sessions for the husbands of the intervention group is as follows: First session: Introduction to the female reproductive system and natural fertilization, introduction to IVF and ICSI and reasons for use, drug preparation, ultrasound and egg retrieval, the husband's supportive role in these stages. Second session: Anxiety during treatment and the problems caused by it, simple anxiety reduction techniques, basic support skills to reduce women's anxiety, extensive social support (family and friends). Session 3: The importance of adequate sleep and the role of the husband in providing a comfortable environment for sleep, healthy nutrition and helping the wife in preparing and choosing the right food, light exercise and encouraging women to move with their husbands, husbands avoiding unhealthy behaviors, husbands taking care of themselves so that they can support women. Session 4: The concept of empathy and examples of it in the treatment process, active listening and examples of it in the treatment process, asking about women's thoughts and feelings, effective companionship methods during treatment, strategies for improving communication and emotional bonding. Infertile women in the intervention group will be supported by their trained husbands during the treatment cycle. The intervention group will also receive routine infertility center consultations from the treatment team, which will include explanations about the fertility treatment method and how to use infertility drugs and their side effects. Finally, they will complete two questionnaires on perceived social support and a state anxiety questionnaire on the day of egg retrieval, while waiting for their turn to undergo the egg retrieval procedure. The number and quality of embryos will also be determined on the third or fifth day after in vitro fertilization using a microscope and based on the embryologist's agreed guidelines. Control group: The control group will receive routine infertility center consultations from the treatment team, which include explanations about the fertility treatment method and how to use infertility drugs and its side effects. Like the intervention group, they will complete two perceived social support questionnaires and a state anxiety questionnaire on the day of egg retrieval, while waiting for their turn to undergo the egg retrieval procedure. The number and quality of embryos will also be determined on the third or fifth day after in vitro fertilization using a microscope and based on guidelines agreed upon by the embryologist. Differences or lack of differences in perceived social support among infertile women undergoing in vitro fertilization (ivf) treatment. Timepoint: Before the intervention and after the intervention on the day of oocyte retrieval. Method of measurement: Multidimensional Perceived Social Support Scale (MSPSS). Differences or lack of differences, in anxietyamong infertile women undergoing in vitro fertilization (ivf) treatment. Timepoint: Before the intervention and after the intervention on the day of oocyte retrieval. Method of measurement: State-Trait Anxiety Inventory, just state anxiety. Difference or lack of difference in treatment outcomes in infertile women undergoing in vitro fertilization (ivf) treatment. Timepoint: After the intervention when the results are known. Method of measurement: The number of eggs is determined through microscopic examination, and the quality of the eggs and embryos, as well as the number of embryos, is assessed using a microscope and according to agreed-upon guidelines by the embryologist. Iran University of Medical Sciences Approved 2025-09-27 Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences Hemmat Expressway, Near Milad Tower Tehran, Iran Tehran Tehran Iran (Islamic Republic of)