Do eye masks and earplugs improve sleep quality and IVF outcomes?
| ISRCTN | ISRCTN39930338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39930338 |
| Sponsor | University Malaya Medical Centre |
| Funder | Department of Medicine, University of Malaya |
- Submission date
- 23/04/2026
- Registration date
- 29/04/2026
- Last edited
- 27/04/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Poor sleep during IVF may impair ovarian response. This study aims to test whether simple, low‑cost sleep aids (eye mask + earplugs) used nightly during controlled ovarian stimulation improve the number of mature oocytes (eggs) at oocyte pick‑up, compared with a sleep‑hygiene leaflet.
Who can participate?
Adults aged 21–42 years with poor sleep (PSQI > 5) undergoing IVF.
What does the study involve?
Participants will be randomized 1:1 to intervention or leaflet. All will wear a wrist actigraphy device to measure sleep objectively and complete short questionnaires. Routine IVF care is unchanged. Primary outcome is oocyte count; secondary outcomes evaluate follicular development, ovarian responsiveness, and successful pregnancy and actigraphy‑derived sleep parameters.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
Obstetric and Gynaecological Department, University Malaya Medical Centre, Malaysia.
When is the study starting and how long is it expected to run for?
May 2026 to May 2027.
Who is funding the study?
1. Investigator initiated and funded
2. University of Malaya Medical Center, Malaysia
Who is the main contact?
Dr Nurul Hafiza MD Khairi, hafizakhairi@gmail.com, ummc@ummc.edu.my.
Contact information
Principal investigator, Scientific, Public
Obstetric and Gynaecological Department
University Malaya Medical Centre
Lembah Pantai
Petaling Jaya
59100
Malaysia
| Phone | +60 03-7949 4422 |
|---|---|
| ummc@ummc.edu.my |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Supportive care |
| Participant information sheet | 49417_PIS_v1_18Nov2025.pdf |
| Scientific title | Effectiveness of eye mask and earplugs versus sleep hygiene leaflet on sleep quality and IVF outcomes among women undergoing in vitro fertilisation: a randomised controlled trial |
| Study objectives | • Primary: To determine whether eye‑mask and earplugs during COS increase the number of MII oocytes at OPU compared to a sleep‑hygiene leaflet. • Secondary: To compare FORT and FOI between arms. • Secondary: To compare clinical pregnancy rate between arms. • Secondary: To compare sleep quality (PSQI) and actigraphy metrics (TST, SE, WASO) between arms. |
| Ethics approval(s) |
Approved 09/04/2026, Medical Research Ethics Committee (MREC), University of Malaya Medical Centre (Lembah Pantai, kuala lumpur, 59100, Malaysia; +60 03-79493209/2251; mrec@ummc.edu.my), ref: 20251118-15900 |
| Health condition(s) or problem(s) studied | Sleep quality |
| Intervention | Methodology: Randomised controlled trial Human subjects: Yes — Patients in UMMC; target n ≈ 170 Sample size justification: Negative binomial regression for MII oocyte; assumption difference of 2 oocytes between intervention group and control group is significance, 90% power for RR≈1.25–1.30 at α=0.05; 10–20% attrition; target ≈170 participants. Vulnerable groups: No This is a single-blinded (assessor) study with two arms - intervention (eye mask and ear plug) versus control ( sleep hygiene leaflet). The intervention group will be given an eye mask and earplugs (EMEP) for 1 week during their IVF stimulation period. The control group will be given a sleep hygiene leaflet during the same period. Then, both arms will undergo oocyte pick-up, when the number of MII oocytes will be compared between the two groups. Randomization was allocated by using random.org with sealed envelopes. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 42 Years |
| Sex | Female |
| Target sample size at registration | 180 |
| Key inclusion criteria | 1. Women 21–42 years undergoing IVF at UMMC 2. PSQI > 5 prior to COS 3. BMI < 35 kg/m² 4. Able to consent, wear actigraphy, and complete questionnaires |
| Key exclusion criteria | 1. Known obstructive sleep apnea 2. Current shift‑work employment 3. Use of hypnotic/sedative medications during COS 4. Ovarian endometrioma requiring surgical management during cycle |
| Date of first enrolment | 04/05/2026 |
| Date of final enrolment | 30/04/2027 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | version 1 | 18/11/2025 | 24/04/2026 | No | No |
| Participant information sheet | version 1 | 18/11/2025 | 24/04/2026 | No | Yes |
| Protocol file | version 2 | 29/01/2026 | 24/04/2026 | No | No |
Additional files
- 49417_Protocol_v2_29Jan2026.pdf
- Protocol file
- 49417_PIS_v1_18Nov2025.pdf
- Participant information sheet
- 49417_Consent Form_v1_18Nov2025.pdf
- Other files
Editorial Notes
24/04/2026: Study’s existence confirmed by the Medical Research Ethics Committee (MREC), University of Malaya Medical Centre, Malaysia.
