Skip to content

Impact of Psychological Counseling on Clinical Pregnancy Rates in Women with Neuropsychological Issues Undergoing Frozen Embryo Transfer: A Single-Center, Parallel-Group, Open-Label, Exploratory Randomized Controlled Trial

Impact of Psychological Counseling on Clinical Pregnancy Rates in Women with Neuropsychological Issues Undergoing Frozen Embryo Transfer: A Single-Center, Parallel-Group, Open-Label, Exploratory Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116827
Enrollment
Unknown
Registered
2026-01-15
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Infertility, Anxiety, Depression, Sleep Disorders

Interventions

Basic Training Group:Basic psychological conseling.
Mindfulness Training Group:Basic psychological conseling and mindfulness training.

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1.Women aged 18-35 undergoing IVF frozen embryo transfer for various causes of infertility; 2.The female participant is permanent residents of the city; 3.The female participant is assessed as having mild to moderate anxiety (GAD-7 score: 5-14), mild to moderate depression (PHQ-9 score: 5-14), poor sleep quality (PSQI score: 5-10), or excessive stress load. 4.The female participant is willing to participate in the study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe anxiety state (GAD-7 score >=15); 2.Severe depression state (PHQ-9 score >=15); 3.Presence of moderate to severe sleep disorder (PSQI score > 10); 4.Participation in other clinical trials within 3 months prior to screening; 5.History of violent behavior; 6.Comorbid severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurologic, or other systemic diseases; 7.Visual or Hearing Impairment, or Reading Comprehension Deficits, Affecting Neuropsychological Assessment; 8.Any factors considered by the clinical team as potentially limiting compliance with the intervention, such as: a) Alcohol or substance abuse within the past 12 months b) Planning to move out of the study service area within the next two years, or planning to be away from the study area for more than 3 months within one year after enrollment c) Significant history of poor compliance with medication or clinic visits;

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy;

Secondary

MeasureTime frame
Patient Health Questionnaire-9, PHQ-9;Patient Health Questionnaire-9, PHQ-9;7-item Generalized Anxiety Disorder Scale, GAD-7;PsychoSocial Index, PSI;

Countries

China

Contacts

Public ContactJiajia Zhai

The Second Hospital of Hebei Medical University

61443904@qq.com+86 311 6600 2721

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026