Dietary Supplements
Conditions
Keywords
DHEA, CoQ10, Tocotrienol, poor ovarian responder, in vitro fertilization
Brief summary
To investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in poor ovarian responders
Detailed description
Background There is a trend for delayed marriage and childbearing worldwide. Women undergoing in vitro fertilization (IVF) cycles are getting older. Women with advanced age are more likely to be poor ovarian responders (PORs) who have poor prognosis in IVF cycles. Numerous studies have shown that DHEA supplementation may improve IVF outcomes in PORs. Additionally, due to poor prognosis of PORs, it is quite common to combine multiple therapies instead of just one treatment. Some studies showed that CoQ10 and tocotrienol are beneficial for fertility. Thus, the aim of this study is to investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in PORs. Objective To investigate the effect of combined DHEA, CoQ10 and Tocotrienol on PORs undergoing IVF cycles Methods The study will be conducted from March 1st, 2022 to December 31st, 2023 in our reproductive center. We plan to enroll 120 PORs undergoing IVF cycles and divided them into four groups: (1) DHEA (n=30): 75 mg DHEA supplementation per day for three months; (2) DHEA + CoQ10 + Tocotrienol (n=30): 75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for three months; (3) Control: no supplementation. Basic characteristics, infertility history, hormone profiles and ovarian reserve will be recorded. We will recheck serum levels of DHEA-S, FSH and AMH after DHEA supplementation. Then, during the IVF cycles, cumulus cells will be collected after oocyte retrieval to analyze genes expression and mitochondrial function. We will follow reproductive outcomes after embryo transfer. Outcome The effect of combined DHEA, CoQ10 and Tocotrienol on cumulus cells and IVF outcomes in PORs
Interventions
DIETARY_SUPPLEMENTDHEA
75 mg DHEA supplementation per day for 3 months before IVF
DIETARY_SUPPLEMENTDHEA+CoQ10+Tocotrienol
75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF
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 44 Years
Healthy volunteers
No
Inclusion criteria
* Age 35\ 44 * BMI18\ 30 kg/m2 * Diminished ovarian reserve (AFC\<5, AMH\<1.2 ng/ml)
Exclusion criteria
* Primary ovarian insufficiency * Congenital uterine anomaly * Severe intrauterine adhesion * Severe male factor * Chromosome anomaly * Malignancy * Donor cycle * having supplementation within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | through study completion, an average of 1.75 year | continuous presence of a fetal heartbeat over 12 weeks of a pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | through study completion, an average of 1.75 year | the presence of a fetal heartbeat at 6-7 weeks of a pregnancy |
| mitochondrial function of cumulus cells | through study completion, an average of 1.75 year | Oxygen consumption rate of cumulus cells |
Countries
Taiwan
Outcome results
None listed