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OpenTrials
Completed

NCT Number: NCT03438812

Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

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

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Key information

Conditions

Poor Responders Dehydroepiandrosterone

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

dehydroepiandrosterone (DHEA)

Dietary Supplement

Participants take DHEA 90 mg daily for two months at least before in vitro fertilization cycles.

Primary outcomes

  1. mitochondria related genes expression

    Time frame: through study completion, an average of 1 year

    cumulus cells genes expression

Secondary outcomes

  1. oocytes

    Time frame: through study completion, an average of 1 year

    retrieved oocytes in number

  2. embryos

    Time frame: numbers will be confirmed 3 days after fertilization

    day 3 embryos in number

  3. pregnancy rate

    Time frame: pregnancy will be confirmed 4 weeks after embryo transfer

    clinical pregnancy rate

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2018
Registry last updated
Feb 18, 2021

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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