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NCT Number: NCT06546774

The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

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.

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Key information

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Kaohsiung City, 886, Taiwan

Location status: Recruiting

Location contact

Kuan-Hao Tsui

CONTACT

[email protected]

+886-7-3422121

Li-Te Lin

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 35-45 years
  • BMI 18-30 kg/m2
  • planning to undergo IVF cycles

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

Treatment and study plan

melatonin

Dietary Supplement

In the study group, patients will receive melatonin supplementation for at least two months prior to IVF cycles

Primary outcomes

  1. Live birth rate (%)

    Time frame: through study completion, an average of 4 year

    a viable infant after 24 weeks of gestation

  2. oxygen consumption rate of mitochodria (%)

    Time frame: through study completion, an average of 4 year

    to assess mitocondrial function in cumulus cells

  3. mRNA levels of cumulus cell genes

    Time frame: through study completion, an average of 4 year

    to assess cumulus cells gene expression analysis

Secondary outcomes

  1. Clinical pregnancy rate (%)

    Time frame: through study completion, an average of 4 year

    the presence of a fetal heartbeat detected via transvaginal sonography at 6-7 weeks of gestation

  2. Ongoing pregnancy rate (%)

    Time frame: through study completion, an average of 4 year

    the continuation of the pregnancy beyond 12 weeks of gestation

  3. Amount of ATP production (moles/min) of mitochodria

    Time frame: through study completion, an average of 4 year

    to assess mitocondrial function in cumulus cells

Study contacts

Contact information is provided by the study sponsor or research team.

Kuan-Hao Tsui

CONTACT

Li-Te Lin

CONTACT

[email protected]

+88673464027

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

The Effect of Melatonin Supplementation on Cumulus Cells and Reproductive Outcomes in Older Women Undergoing IVF Cycles

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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