Clinical trial NCT06546774: The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes
Official title: The Effect of Melatonin Supplementation on Cumulus Cells and Reproductive Outcomes in Older Women Undergoing IVF Cycles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unrecognized Condition
Keywords: Melatonin
Cumulus cells
In vitro fertilization
Old women
Infertility
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Live birth rate (%)
timeFrame: through study completion, an average of 4 year
measure: oxygen consumption rate of mitochodria (%)
timeFrame: through study completion, an average of 4 year
measure: mRNA levels of cumulus cell genes
timeFrame: through study completion, an average of 4 year
Secondary outcomes:
measure: Clinical pregnancy rate (%)
timeFrame: through study completion, an average of 4 year
measure: Ongoing pregnancy rate (%)
timeFrame: through study completion, an average of 4 year
measure: Amount of ATP production (moles/min) of mitochodria
timeFrame: through study completion, an average of 4 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kuan-Hao Tsui
role: STUDY_DIRECTOR
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