Effectiveness of Adjuvant Supplements Prior to in IVF

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Dietary Supplements

Treatments: Dietary Supplement: DHEA+CoQ10+Tocotrienol; Dietary Supplement: DHEA

Study type: Interventional

Funder types: Other

Identifiers

NCT05471453

KSVGH21-CT8-13

Details and patient eligibility

About

To investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in poor ovarian responders

Full 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

Enrollment: 70 patients

Sex: Female

Ages: 35 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

DHEA group

Sham Comparator group

Description:

75 mg DHEA supplementation per day for 3 months before IVF

Treatment:

Dietary Supplement: DHEA

DHEA+CoQ10+Tocotrienol group

Experimental group

Description:

75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF

Treatment:

Dietary Supplement: DHEA+CoQ10+Tocotrienol

Control group

No Intervention group

Description:

No supplementation before IVF