Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

February 17, 2021 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

The Role of Dehydroepiandrosterone in the Maintenance of Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

To investigate whether the DHEA supplementation could improve mitochondrial quality in poor ovarian responders

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women who underwent in vitro fertilization (IVF) treatment participated, including normal ovarian responders (NORs) and poor ovarian responders (PORs). PORs were assigned to receive DHEA supplementation or not before the IVF cycle. For all patients, cumulus cells (CCs) were obtained after oocyte retrieval. In the CCs, mRNA expression of mitochondria-related genes was measured. To compare the mRNA expression of mitochondria-related genes in the CCs among the three groups.

Study Type

Interventional

Enrollment (Actual)

66

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, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital

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

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Poor ovarian responders met the Bologna criteria, having at least two of the three following features: (1) advanced maternal age (≥ 40 years) or any other risk factor for POR, (2) a previous POR (≤ 3 oocytes with a conventional stimulation protocol), and (3) an abnormal ovarian reserve test. An abnormal ovarian reserve test was defined as antral follicle counts (AFC) < 5 or anti-Müllerian hormone (AMH) < 1 ng/mL in this study.
  • Normal ovarian responders met the following criteria: (1) AFCs ≥ 5 or AMH ≥ 1 ng/mL and (2) the number of retrieved oocytes was between 5 and 15.

Exclusion Criteria:

  • previous oophorectomy
  • exposure to cytotoxic or pelvic irradiation for malignancy
  • positive screening for recurrent pregnancy loss (chromosome mapping, antinuclear antibodies, extractable nuclear antigens, antiphospholipid antibodies, thrombophilic screening)
  • any other sensitizing or ovarian stimulating therapy during the previous 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Poor ovarian responders with DHEA
Women who meet the Bologna criteria receive dehydroepiandrosterone (DHEA, 90 mg daily for two months at least) supplementation prior to the IVF cycle.
Dietary supplement: dehydroepiandrosterone (DHEA)
Participants take DHEA 90 mg daily for two months at least before in vitro fertilization cycles.
NO_INTERVENTION: Poor ovarian responders
Women who meet the Bologna criteria undergo the IVF cycle without pretreatment with DHEA
NO_INTERVENTION: Normal ovarian responders
Women who do not meet the Bologna criteria and have normal ovarian response to ovarian stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mitochondria related genes expression
Time Frame: through study completion, an average of 1 year
cumulus cells genes expression
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oocytes
Time Frame: through study completion, an average of 1 year
retrieved oocytes in number
through study completion, an average of 1 year
embryos
Time Frame: numbers will be confirmed 3 days after fertilization
day 3 embryos in number
numbers will be confirmed 3 days after fertilization
pregnancy rate
Time Frame: pregnancy will be confirmed 4 weeks after embryo transfer
clinical pregnancy rate
pregnancy will be confirmed 4 weeks after embryo transfer

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, Ph.D., Kaohsiung Veterans General Hospital.
  • Principal Investigator: Li-Te Lin, Ph.D., 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)

September 6, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

February 4, 2018

First Submitted That Met QC Criteria

February 17, 2018

First Posted (ACTUAL)

February 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS14-CT10-16

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.

Clinical Trials on Poor Responders

Clinical Trials on dehydroepiandrosterone (DHEA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe