Effectiveness of Adjuvant Supplements Prior to in IVF

Not Applicable

Completed

• Conditions: Dietary Supplements
• Interventions: Dietary Supplement: DHEA; Dietary Supplement: DHEA+CoQ10+Tocotrienol

• Registration Number: NCT05471453
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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

Study Timeline

• Study Start: 2022-03-02
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; 🇨🇳 Kaohsiung, Taiwan