InfertilityNCT07343947
Melatonin Supplementation in Ovarian Response
A study testing 5mg melatonin supplementation in people with Infertility and Infertility (IVF Patients), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Infertility (IVF Patients), Infertile Women Undergoing IVF or ICSI
- What is being tested?
- 5mg melatonin supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jan 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women aged 18-40 years
- No previous infertility treatment
- No previous hormonal treatment
- No previous radio-chemotherapy treatment
Who cannot join
- Fertile women
- Previous hormonal treatment
- Previous radio-chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- 5mg melatonin supplementation, Sham (No Treatment)
- Keywords
- IVF, Infertile women, Melatonin, follicular fluid, ovarian response
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg melatonin supplementationDrug
5 mg melatonin suplementation
Sham (No Treatment)Other
Sham (no treatment)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Other: Sham (No Treatment) |
| Melatonin suplementation | Experimental | Not described Receives: Drug: 5mg melatonin supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular fluid melatonin concentration
Measured: Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks
Secondary outcomes (1)
Reprodutive outcomes
(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).
Measured: From the enrollment to the end of treatment at 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start31 Jan 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Maria Soares Junior, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343947
- Sponsor's protocol ID
- CEP-USP No. 4,996,660
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29186759Kloss 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.
PubMed 25458772Fernando 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.
PubMed 25330986Schwertner 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.
PubMed 23602498Ruder 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.
PubMed 18535004Reiter 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.
PubMed 27500468Vander 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.
PubMed 29555319
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Supplementation in Ovarian Response: a Double-blind Randomized Controlled Trial on Follicular Fluid Melatonin Levels and Reproductive Outcomes in Infertile Women
- ClinicalTrials.gov ID
- NCT07343947
- Acronym / sponsor ID
- CEP-USP No. 4,996,660
- Keywords
- IVF, Infertile women, Melatonin, follicular fluid, ovarian response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Sham (No Treatment) |
| Melatonin suplementation | Experimental | Drug: 5mg melatonin supplementation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile women aged 18-40 years
- No previous infertility treatment
- No previous hormonal treatment
- No previous radio-chemotherapy treatment
Key exclusion criteria (3 listed)
- Fertile women
- Previous hormonal treatment
- Previous radio-chemotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5mg melatonin supplementation5 mg melatonin suplementation | Drug | Melatonin suplementation |
| Sham (No Treatment)Sham (no treatment) | Other | Control |
Primary outcome
Follicular fluid melatonin concentration
Time frame: Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks
1 secondary outcome
Reprodutive outcomes
Time frame: From the enrollment to the end of treatment at 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 29186759Jamilian 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.
- Results publication: PubMed 25458772Kloss 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.
- Results publication: PubMed 25330986Fernando 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.
- Results publication: PubMed 23602498Schwertner 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.
- Results publication: PubMed 18535004Ruder 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.
- Results publication: PubMed 27500468Reiter 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.
- Results publication: PubMed 29555319Vander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5mg melatonin supplementation in people with Infertility and Infertility (IVF Patients), run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular fluid melatonin concentration (time frame: Baseline (pre-intervention), periprocedurally and in the end of treatment at 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07343947, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.