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IRCT20251026067770N5 IRCT 2025-12-25 Islamic Azad University Comparing Mindfulness-Based Cognitive Behavioral Therapy with Usual Care to Reduce Anxiety and Improve Sperm Measures in Infertile Men Comparing the Effectiveness of Mindfulness-Based Cognitive Behavioral Therapy Versus Usual Care in Reducing Anxiety and Improving Sperm Parameters (Count, Motility, and Morphology) in Infertile Men 2025-12-31 anticipated 60 Complete https://irct.ir/trial/88286 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be conducted using the Randomization.com website. The random allocation sequence will be generated by an independent statistician who is not involved in study implementation or outcome assessment. Random permuted blocks with variable block sizes (4 and 6) will be used to maintain balance between the two groups: the “mindfulness-based cognitive behavioral therapy” group and the “no-intervention control” group. Allocation codes will be placed in sequentially numbered, sealed, opaque envelopes to ensure concealment of the random sequence until each participant is enrolled. Upon enrollment, the envelope corresponding to the participant’s order of entry will be opened by the staff member responsible for registration, and the participant will be assigned to the indicated group, Blinding description: Randomization will be performed using the website https://www.randomization.com.The random allocation list will be generated by a statistician who is not involved in participant recruitment or outcome assessment. A block randomization method with variable block sizes (4 and 6) will be used to ensure balanced group sizes between the Gestalt Therapy group and the no-intervention control group. The allocation codes will be sealed in opaque, sequentially numbered envelopes to maintain allocation concealment until each participant is enrolled. Upon enrollment, the next envelope in sequence will be opened by the registration officer, and the participant will be assigned to the corresponding group. N/A Male infertility. Intervention 1: Intervention group: Group-based mindfulness-based cognitive therapy will be delivered in 8 weekly 120-minute sessions by a trained therapist. Sessions include mindfulness practices (body scan, mindful breathing, sitting meditation, mindful movement) integrated with cognitive–behavioral skills (identifying automatic thoughts/rumination, cognitive restructuring, emotion regulation), plus daily home practice (20–45 min) supported by guided audio and practice logs. Attendance and adherence will be recorded. Intervention 2: Control group: Participants in this group will receive usual medical care and routine clinical follow-up related to infertility, and no structured psychotherapy intervention will be provided. At baseline, they will be given brief general information on basic principles of stress management and mental health; however, no therapy sessions or structured training will be delivered. After completion of the study, participants in the control group will be offered the opportunity to take part in the mindfulness-based cognitive behavioral therapy program. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The final policy regarding sharing of individual participant data (IPD) has not yet been determined. Anonymized data may potentially be shared in the future upon reasonable request from qualified researchers and subject to ethics approval, but this has not been finalized.
public Kosar Bardideh
No. 56, After Boostan, 11 South Khayyam, Khayyam Boulevard
Mashhad Iran (Islamic Republic of) 9174658155 +98 51 3761 8121 kbardideh@yahoo.com Islamic Azad University scientific Naser Aghababaei
No. X, Fadaei St., Imam Hadi Sq., University of Quran and Hadith
Tehran Iran (Islamic Republic of) 1876943116 +98 21 3711 1430 Naseragha@gmail.com University of Quran and Hadith Iran (Islamic Republic of) Having a confirmed diagnosis of infertility by a specialist physician Obtaining a high score on the Spielberger State-Trait Anxiety Inventory (STAI) Providing informed consent to participate in the study Being between 25 and 65 years of age Having at least five years of infertility 25 years 65 years Male Pregnancy of the spouse Lack of willingness to continue participation in the study Absence from more than three sessions Use of any psychiatric medication in the past three months, or participation in psychotherapy sessions within the past six months Presence of any personality disorder or transient psychotic features, as assessed by the Minnesota Multiphasic Personality Inventory (MMPI) N46 Male infertility Treatment - Other Treatment - Other Intervention group: Group-based mindfulness-based cognitive therapy will be delivered in 8 weekly 120-minute sessions by a trained therapist. Sessions include mindfulness practices (body scan, mindful breathing, sitting meditation, mindful movement) integrated with cognitive–behavioral skills (identifying automatic thoughts/rumination, cognitive restructuring, emotion regulation), plus daily home practice (20–45 min) supported by guided audio and practice logs. Attendance and adherence will be recorded. Control group: Participants in this group will receive usual medical care and routine clinical follow-up related to infertility, and no structured psychotherapy intervention will be provided. At baseline, they will be given brief general information on basic principles of stress management and mental health; however, no therapy sessions or structured training will be delivered. After completion of the study, participants in the control group will be offered the opportunity to take part in the mindfulness-based cognitive behavioral therapy program Anxiety score on the State–Trait Anxiety Inventory (STAI) developed by Spielberger. Timepoint: At the beginning of the study (before the intervention) and after the end of the intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory. Sperm Count: Outcome description (English):Sperm count per milliliter of semen, measured through a standard laboratory semen analysis and reported in million/mL. Timepoint: At the beginning of the study (before the intervention) and after the end of the intervention. Method of measurement: Sperm count is measured through a standard laboratory semen analysis performed according to the guidelines of the World Health Organization. Sperm Motility: Percentage of sperm with progressive and non-progressive motility, assessed according to WHO criteria in a standard semen analysis. Timepoint: At the beginning of the study (before the intervention) and after the end of the intervention. Method of measurement: Sperm motility is assessed through microscopic examination of the semen sample as part of a standard semen analysis, following the criteria of the World Health Organization. Sperm Morphology: Percentage of sperm with normal morphology based on WHO standards, determined via microscopic examination of the semen sample. Timepoint: At the beginning of the study (before the intervention) and after the end of the intervention. Method of measurement: Sperm morphology is evaluated through microscopic assessment of the semen sample based on the morphology criteria of the World Health Organization within a standard semen analysis. Islamic Azad University Approved 2025-01-27 Medical Research Ethics Committee, Faculty of Medicine, Islamic Azad University, North Tehran Branch 5th Floor, Shahid Fakhrizadeh Research and Laboratory Building, Islamic Azad University, North Tehran Branch, Vafadar Boulevard, Shahid Sadooghi Street, Hakimiyeh Exit, Shahid Babayi Expressway (West to East) Tehran Tehran Iran (Islamic Republic of)