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Evaluation of melatonin supplementation on infertile couples

Comparison of the effectiveness of melatonin supplementation with placebo on oxidative and inflammatory stress markers in infertile couples with unknown cause.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240415061493N1
Enrollment
84
Registered
2024-04-29
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility. Female infertility, unspecified

Interventions

Intervention 1: Intervention group: Melatonin will be prescribed for two months in the form of 6 mg every night from the beginning of the cycle of the month before IUI to the end of the IUI cycle. Int

Sponsors

Yasouj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 42 Years

Inclusion criteria

Inclusion criteria: Absence of uterine and tubal anomalies in women and absence of genital anomalies and varicocele in men. Absence of underlying disease in couples Absence of smoking, tobacco, drugs and alcohol in couples Body mass index (BMI) less than 35 in women Normal sperm analysis Normal hysterosalpingography (HSG) of the lady Ovary storage suitable for women Not taking antioxidant drugs

Exclusion criteria

Exclusion criteria: Cause a complication during the study for the patient Unwillingness to continue cooperation of the patient

Design outcomes

Primary

MeasureTime frame
1- Determination and comparison of the amount of TNF-a in infertile couples with an unknown cause receiving melatonin supplementation compared to the control group before and after the study 2- Determination and comparison of the CRP level in infertile couples with an unknown cause receiving melatonin supplementation compared to the group Control before and after the study 3- Determine and compare the level of SOD activity in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study 4- Determine and compare the level of CAT activity in infertile couples with an unknown cause receiving Melatonin supplementation compared to the control group before and after the study 5- Determining and comparing the level of GPX activity in infertile couples with an unknown cause receiving melatonin supplementation compared to the control group before and after the study 6- Determining and comparing the MDA level in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.7- Determining and comparing the amount of protein carbonyl (PCO) in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.8- Determining and comparing the total antioxidant capacity of plasma (FRAP) in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.9- Determining and comparing the amount of nitric oxide (NO) metabolites in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study. 10- Determining and comparing the amount of melatonin in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.11- Determining the rate of pregnancy success after IUI in infertile couples with an unkn

Secondary

MeasureTime frame
Determining the rate of pregnancy success after IUI in infertile couples with an unknown cause receiving melatonin supplements compared to the control group. Timepoint: After completing the study. Method of measurement: bhcg measurement, vaginal sonography at 7 weeks, no pregnancy loss until 20 weeks.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaran Golmohamadi

Yasouj University of Medical Sciences

nastaran.golmohamadi@yums.ac.ir+98 13 3355 4772

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026