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Completed

NCT Number: NCT07343947

Melatonin Supplementation in Ovarian Response

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.

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Key information

Conditions

Infertility Genital Diseases Infertile Women Undergoing IVF or ICSI Infertility (IVF Patients) Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Univertity of Sao Paulo, Clinics Hospital

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5mg melatonin supplementation

Drug

5 mg melatonin suplementation

Sham (No Treatment)

Other

Sham (no treatment)

Primary outcomes

  1. Follicular fluid melatonin concentration

    Time frame: Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks

Secondary outcomes

  1. Reprodutive outcomes

    Time frame: From the enrollment to the end of treatment at 7 weeks

    (1) oocyte maturation rate (MII/oocytes retrieved), (2) blastocyst formation rate, (3) implantation rate (gestational sacs per embryo transferred), and (4) clinical pregnancy rate (ultrasound-confirmed at 7 weeks).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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