Melatonin Supplementation in Ovarian Response

University of Sao Paulo General Hospital

Status: Completed

Conditions: Infertility; Infertility (IVF Patients); Infertile Women Undergoing IVF or ICSI

Treatments: Drug: 5mg melatonin supplementation; Other: Sham (No Treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT07343947

CEP-USP No. 4,996,660

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infertile women aged 18-40 years
• No previous infertility treatment
• No previous hormonal treatment
• No previous radio-chemotherapy treatment

Exclusion criteria

• Fertile women
• Previous hormonal treatment
• Previous radio-chemotherapy treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Other: Sham (No Treatment)

Melatonin suplementation

Experimental group

Treatment:

Drug: 5mg melatonin supplementation