Melatonin Supplementation in Ovarian Response

January 6, 2026 updated by: Jose Maria Soares Junior, University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil
        • Univertity of Sao Paulo, Clinics Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Other: Sham (No Treatment)
Sham (no treatment)
Experimental: Melatonin suplementation
Drug: 5mg melatonin supplementation
5 mg melatonin suplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Follicular fluid melatonin concentration
Time Frame: Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks
Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From the enrollment to the end of treatment at 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP-USP No. 4,996,660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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