Effect of Mindfulness Training on the Clinical Pregnancy Rate in Women Undergoing Frozen Embryo Transfer: Study Protocol for a Single-Center, Open-Label, Randomized Controlled Trial.
Songping Yi, Junyan Zhang, Aimin Li, Na Zhou, Jing Li, Ruxue Cao, Yuan Gao, Xiaolei Liu, Jiajia Zhai
International journal of women's health June 20, 2026 DOI: 10.2147/ijwh.s598680 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Open-label Peer reviewed |
|---|---|
| Sample size | 434 |
| Population | Women aged 18-45 years undergoing frozen embryo transfer (FET) with psychological distress (mild to moderate anxiety symptoms, depressive symptoms, poor sleep quality, or psychosocial stress overload) |
| Interventions | Mindfulness training Essential psychological counseling |
| Topics | Meditation |
| Keywords | Randomized controlled trial Psychological distress Frozen embryo transfer Clinical pregnancy |
| Key findings | The protocol proposes to test whether structured mindfulness training added to essential psychological counseling increases the clinical pregnancy rate in women undergoing FET with psychological distress, compared with counseling alone. It also plans to examine whether neuropsychological improvements mediate any effect of mindfulness on pregnancy, and to assess anxiety, depressive symptoms, sleep quality, psychosocial stress, and live birth as secondary or exploratory outcomes. |
Abstract
Objective: To evaluate the effect of mindfulness training in addition to essential psychological counseling on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET), and to explore the potential mediating role of neuropsychological improvements. Methods and analysis: This study will be conducted as a single-center, parallel-group, open-label, exploratory randomized controlled trial. Eligible women aged 18-45 years undergoing FET who present with psychological distress (mild to moderate anxiety symptoms, depressive symptoms, poor sleep quality, or psychosocial stress overload) will be recruited. Participants will be randomly assigned in a 1:1 ratio to either the Mindfulness Training Group (MTG), which delivers structured formal mindfulness practice, or the Essential Psychological Counseling Group (EPCG), which provides supportive psychoeducation and emotional guidance without mindfulness-based training. The primary endpoint will be the clinical pregnancy rate. Secondary endpoints include changes in anxiety symptoms, depressive symptom, sleep quality, and psychosocial stress; the live birth rate will be assessed exploratorily. Mediation analyses will be performed to assess whether neuropsychological improvements explain the relationship between mindfulness training and clinical pregnancy. A total of 434 participants will be enrolled, allowing for a 20% dropout rate.
Trial Registration: This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2600116827).
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |