The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

August 9, 2024 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kuan-Hao Tsui

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 886
        • Recruiting
        • Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
        • Principal Investigator:
          • Li-Te Lin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin group
Patients received melatonin supplementation for at least a two-month period prior to IVF cycles
Dietary supplement: Melatonin
In the study group, patients will receive melatonin supplementation for at least two months prior to IVF cycles
No Intervention: Control group
Patients did not receive melatonin supplementation and proceeded directly to IVF cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRNA levels of cumulus cell genes
Time Frame: through study completion, an average of 4 year
to assess cumulus cells gene expression analysis
through study completion, an average of 4 year
Live birth rate (%)
Time Frame: through study completion, an average of 4 year
a viable infant after 24 weeks of gestation
through study completion, an average of 4 year
oxygen consumption rate of mitochodria (%)
Time Frame: through study completion, an average of 4 year
to assess mitocondrial function in cumulus cells
through study completion, an average of 4 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 4 year
Ongoing pregnancy rate (%)
Time Frame: through study completion, an average of 4 year
the continuation of the pregnancy beyond 12 weeks of gestation
through study completion, an average of 4 year
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
through study completion, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Study Director: Kuan-Hao Tsui, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSVGH21-CT1-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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