NCT07343947

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

December 2, 2025

Last Update Submit

January 6, 2026

Conditions

InfertilityInfertility (IVF Patients)Infertile Women Undergoing IVF or ICSI

Keywords

IVFInfertile womenMelatoninfollicular fluidovarian response

Outcome Measures

Primary Outcomes (1)

  • Follicular fluid melatonin concentration

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

Secondary Outcomes (1)

  • Reprodutive outcomes

    From the enrollment to the end of treatment at 7 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR
Other: Sham (No Treatment)

Melatonin suplementation

EXPERIMENTAL
Drug: 5mg melatonin supplementation

Interventions

5mg melatonin supplementationDRUG

5 mg melatonin suplementation

Melatonin suplementation
Sham (No Treatment)OTHER

Sham (no treatment)

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univertity of Sao Paulo, Clinics Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (7)

  • Jamilian M, Foroozanfard F, Rahmani E, Talebi M, Bahmani F, Asemi Z. Effect of Two Different Doses of Vitamin D Supplementation on Metabolic Profiles of Insulin-Resistant Patients with Polycystic Ovary Syndrome. Nutrients. 2017 Nov 24;9(12):1280. doi: 10.3390/nu9121280.

    PMID: 29186759RESULT

  • Kloss JD, Perlis ML, Zamzow JA, Culnan EJ, Gracia CR. Sleep, sleep disturbance, and fertility in women. Sleep Med Rev. 2015 Aug;22:78-87. doi: 10.1016/j.smrv.2014.10.005. Epub 2014 Oct 18.

    PMID: 25458772RESULT

  • Fernando S, Rombauts L. Melatonin: shedding light on infertility?--A review of the recent literature. J Ovarian Res. 2014 Oct 21;7:98. doi: 10.1186/s13048-014-0098-y.

    PMID: 25330986RESULT

  • Schwertner A, Conceicao Dos Santos CC, Costa GD, Deitos A, de Souza A, de Souza IC, Torres IL, da Cunha Filho JS, Caumo W. Efficacy of melatonin in the treatment of endometriosis: a phase II, randomized, double-blind, placebo-controlled trial. Pain. 2013 Jun;154(6):874-81. doi: 10.1016/j.pain.2013.02.025. Epub 2013 Mar 5.

    PMID: 23602498RESULT

  • Ruder EH, Hartman TJ, Blumberg J, Goldman MB. Oxidative stress and antioxidants: exposure and impact on female fertility. Hum Reprod Update. 2008 Jul-Aug;14(4):345-57. doi: 10.1093/humupd/dmn011. Epub 2008 Jun 4.

    PMID: 18535004RESULT

  • Reiter RJ, Mayo JC, Tan DX, Sainz RM, Alatorre-Jimenez M, Qin L. Melatonin as an antioxidant: under promises but over delivers. J Pineal Res. 2016 Oct;61(3):253-78. doi: 10.1111/jpi.12360. Epub 2016 Sep 1.

    PMID: 27500468RESULT

  • Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clin Biochem. 2018 Dec;62:2-10. doi: 10.1016/j.clinbiochem.2018.03.012. Epub 2018 Mar 16.

    PMID: 29555319RESULT

MeSH Terms

Conditions

Infertility

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gynecology Department, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

December 2, 2025

First Posted

January 15, 2026

Study Start

January 31, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)