Alpha-Lipoic Acid Supplementation and IVF Outcomes in Women of Advanced Maternal Age
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-45
SponsorKaohsiung Veterans General Hospital.
About this trial
Female fertility declines with advancing age, largely because of deteriorating oocyte quality driven by mitochondrial dysfunction and oxidative stress within the ovarian microenvironment. Alpha-lipoic acid (ALA) is a potent antioxidant that crosses cell and mitochondrial membranes, regenerates other antioxidants (vitamin C, vitamin E, glutathione, coenzyme Q10), and supports mitochondrial respiratory chain activity and ATP production. This prospective study will enroll 60 infertile women aged 35-45 years undergoing in vitro fertilization (IVF) treatment. Thirty participants will receive oral ALA 600 mg/day for two months before their IVF cycle, and thirty will proceed directly to IVF without supplementation. The study will compare oocyte and embryo quality, cumulus cell mitochondrial function and metabolic gene expression, and clinical pregnancy and live birth rates between the two groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 35-45 years
BMI 18-35 kg/m²
Planning to undergo IVF treatment using own oocytes
Disqualifiers
Primary ovarian insufficiency
Azoospermia or severe male-factor infertility in the partner
Congenital uterine anomaly
Severe intrauterine adhesion
Trial design
Design model
Parallel
Treatments tested in this trial
Alpha-Lipoic Acid (ALA)
Dietary supplementOral Alpha-Lipoic Acid 600 mg/day for 2 months prior to IVF cycle initiation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Alpha-Lipoic Acid + IVFExperimental treatment 1 intervention
Group B: Standard IVF (Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Embryo quality
proportion of top-grade embryos (Day 3) or blastocysts (Day 5) per standard grading criteria
Time frame
through study completion, an average of 1 year2
Cumulus cell mitochondrial function
ATP content, mitochondrial membrane potential, ROS level, and mitochondrial DNA copy number
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Clinical pregnancy rate
presence of a gestational sac with fetal heartbeat on transvaginal ultrasound at 6-7 weeks' gestation
Time frame
through study completion, an average of 1 year2
Live birth rate
delivery of a live infant after 24 weeks' gestation
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov