Do eye masks and earplugs improve sleep quality and IVF outcomes?

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39930338

Enrollment

180

Registered

2026-04-29

Start date

2026-05-04

Completion date

Unknown

Last updated

2026-05-11

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

Conditions

Sleep quality Pregnancy and Childbirth

Interventions

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 a=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 intervent

Eligibility

Sex/Gender

Female

Age

21 Years to 42 Years

Inclusion criteria

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

Exclusion criteria

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

Countries

Malaysia

Contacts

Public ContactNurul Hafiza MD Khairi

ummc@ummc.edu.my+60 03-7949 4422

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026