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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251026067770N5
Enrollment
60
Registered
2025-12-25
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male infertility. Male infertility

Interventions

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 (bo
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-

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKosar Bardideh

Islamic Azad University

kbardideh@yahoo.com+98 51 3761 8121

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026