NCT07343947

Melatonin Supplementation in Ovarian Response

Melatonin Supplementation in Ovarian Response: a Double-blind Randomized Controlled Trial on Follicular Fluid Melatonin Levels and Reproductive Outcomes in Infertile Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Melatonin is a potent antioxidant, has been proposed to improve ovarian response and oocyte quality in assisted reproductive technologies (ART). This study evaluated the effects of melatonin supplementation on follicular fluid melatonin levels, hormonal profiles, and reproductive outcomes in women undergoing in vitro fertilization (IVF). Follicular fluid and serum melatonin levels, oocyte quality, embryo development, and pregnancy rates were assessed.

Detailed description

Background: Melatonin, a potent antioxidant, has been proposed to improve ovarian response and oocyte quality in assisted reproductive technologies (ART). This study evaluated the effects of melatonin supplementation on follicular fluid melatonin levels, hormonal profiles, and reproductive outcomes in women undergoing in vitro fertilization (IVF). Methods: In this double-blind, randomized controlled trial, 80 infertile women were allocated to receive either 5 mg melatonin nightly (n=40) or placebo (n=40) during ovarian stimulation. Follicular fluid and serum melatonin levels, oocyte quality, embryo development, and pregnancy rates were assessed. Statistical analyses included Mann-Whitney U tests for continuous variables and chi-square/Fisher's tests for categorical data.

Conditions

• Infertility
• Infertility (IVF Patients)
• Infertile Women Undergoing IVF or ICSI

Interventions

Type	Name	Description
DRUG	5mg melatonin supplementation	5 mg melatonin suplementation
OTHER	Sham (No Treatment)	Sham (no treatment)

Timeline

• Start date: 2022-01-31
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: Brazil