The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

Last updated: August 9, 2024
Sponsor: Kaohsiung Veterans General Hospital.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Melatonin

Clinical Study ID

NCT06546774
KSVGH21-CT1-43
  • Ages 35-45
  • Female

Study Summary

This study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. Cumulus cells will be collected after oocyte retrieval, and IVF outcomes will be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 35-45 years

  • BMI 18-30 kg/m2

  • planning to undergo IVF cycles

Exclusion

Exclusion Criteria:

  • Primary ovarian insufficiency

  • history of oophorectomy

  • receiving oocyte donation

  • Chromosome anomaly

  • Congenital uterine anomaly

  • Severe intrauterine adhesion

  • Malignancy

  • Using hormone therapy or supplements in recent 3 months

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Melatonin
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
December 31, 2025

Study Description

Aging in female reproductive cells, particularly cumulus granulosa cells, is associated with various dysfunctions that compromise fertility. Melatonin, a hormone primarily produced by the pineal gland, is renowned for its multifaceted roles in regulating physiological processes, including sleep-wake cycles, immune function, and antioxidative defense. Melatonin's antioxidant action is mediated through direct scavenging of free radicals, upregulation of antioxidant enzymes, and improvement of mitochondrial efficiency. These properties make melatonin a promising candidate for mitigating the adverse effects of aging on cellular function. This study aims to explore the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. In the control group, patients will proceed directly to IVF cycles without melatonin supplementation. Cumulus cells will be collected after oocyte retrieval, and gene expression will be measured. Additionally, clinical pregnancy rate, live birth rate, and miscarriage rate between the two groups will be evaluated.

Connect with a study center

  • Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

    Kaohsiung, 886
    Taiwan

    Active - Recruiting

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