Clinical trial NCT05471453: Effectiveness of Adjuvant Supplements Prior to in IVF
Official title: To Investigate the Effectiveness of Adjuvant Supplements Prior to in Vitro Fertilization Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplements
Keywords: DHEA
CoQ10
Tocotrienol
poor ovarian responder
in vitro fertilization
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: through study completion, an average of 1.75 year
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: through study completion, an average of 1.75 year
measure: mitochondrial function of cumulus cells
timeFrame: through study completion, an average of 1.75 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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