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Completed

NCT Number: NCT05471453

Effectiveness of Adjuvant Supplements Prior to in IVF

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

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Key information

Conditions

Dietary Supplements

Age range

35 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Kaohsiung City, 886, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHEA

Dietary Supplement

75 mg DHEA supplementation per day for 3 months before IVF

DHEA+CoQ10+Tocotrienol

Dietary Supplement

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

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: through study completion, an average of 1.75 year

    continuous presence of a fetal heartbeat over 12 weeks of a pregnancy

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: through study completion, an average of 1.75 year

    the presence of a fetal heartbeat at 6-7 weeks of a pregnancy

  2. mitochondrial function of cumulus cells

    Time frame: through study completion, an average of 1.75 year

    Oxygen consumption rate of cumulus cells

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

To Investigate the Effectiveness of Adjuvant Supplements Prior to in Vitro Fertilization Cycles

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2022
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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