Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2022-01-31
2023-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Sham (No Treatment)
Sham (no treatment)
Melatonin suplementation
5mg melatonin supplementation
5 mg melatonin suplementation
Interventions
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5mg melatonin supplementation
5 mg melatonin suplementation
Sham (No Treatment)
Sham (no treatment)
Eligibility Criteria
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Inclusion Criteria
* No previous infertility treatment
* No previous hormonal treatment
* No previous radio-chemotherapy treatment
Exclusion Criteria
* Previous hormonal treatment
* Previous radio-chemotherapy treatment
18 Years
40 Years
FEMALE
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Jose Maria Soares Junior
Head of Gynecology Department, Principal Investigator, Clinical Professor
Locations
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Univertity of Sao Paulo, Clinics Hospital
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CEP-USP No. 4,996,660
Identifier Type: -
Identifier Source: org_study_id
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