Unrecognized Condition
Conditions
Keywords
Melatonin, Cumulus cells, In vitro fertilization, Old women, Infertility
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.
Interventions
DIETARY_SUPPLEMENTMelatonin
In the study group, patients will receive melatonin supplementation for at least two months prior to IVF cycles
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate (%) | through study completion, an average of 4 year | a viable infant after 24 weeks of gestation |
| oxygen consumption rate of mitochodria (%) | through study completion, an average of 4 year | to assess mitocondrial function in cumulus cells |
| mRNA levels of cumulus cell genes | through study completion, an average of 4 year | to assess cumulus cells gene expression analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate (%) | through study completion, an average of 4 year | the presence of a fetal heartbeat detected via transvaginal sonography at 6-7 weeks of gestation |
| Ongoing pregnancy rate (%) | through study completion, an average of 4 year | the continuation of the pregnancy beyond 12 weeks of gestation |
| Amount of ATP production (moles/min) of mitochodria | through study completion, an average of 4 year | to assess mitocondrial function in cumulus cells |
Countries
Taiwan
Contacts
Primary ContactLi-Te Lin
Backup ContactKuan-Hao Tsui
Outcome results
None listed