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
Sleep quality
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.
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
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