The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

Kaohsiung Veterans General Hospital

Status: Enrolling

Conditions: Unrecognized Condition

Treatments: Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT06546774

KSVGH21-CT1-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 35 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Melatonin group

Experimental group

Description:

Patients received melatonin supplementation for at least a two-month period prior to IVF cycles

Treatment:

Dietary Supplement: Melatonin

Control group

No Intervention group

Description:

Patients did not receive melatonin supplementation and proceeded directly to IVF cycles