Effectiveness of Adjuvant Supplements Prior to in IVF

August 1, 2024 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 886
        • Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: DHEA group
75 mg DHEA supplementation per day for 3 months before IVF
Dietary supplement: DHEA
75 mg DHEA supplementation per day for 3 months before IVF
Experimental: DHEA+CoQ10+Tocotrienol group
75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF
Dietary supplement: DHEA+CoQ10+Tocotrienol
75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF
No Intervention: Control group
No supplementation before IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1.75 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1.75 year
mitochondrial function of cumulus cells
Time Frame: through study completion, an average of 1.75 year
Oxygen consumption rate of cumulus cells
through study completion, an average of 1.75 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Study Director: Kuan-Hao Tsui, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

July 21, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSVGH21-CT8-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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