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Trial record 9 of 235 for:    PRASTERONE

Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438812
Recruitment Status : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Li-Te Lin, Kaohsiung Veterans General Hospital.

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

Condition or disease Intervention/treatment Phase
Poor Responders Dehydroepiandrosterone Dietary Supplement: dehydroepiandrosterone (DHEA) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Dehydroepiandrosterone in the Maintenance of Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

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.



Primary Outcome Measures :
  1. mitochondria related genes expression [ Time Frame: through study completion, an average of 1 year ]
    cumulus cells genes expression


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438812


Locations
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Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 81362
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81362
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Study Director: Kuan-Hao Tsui, Ph.D. Kaohsiung Veterans General Hospital.
Principal Investigator: Li-Te Lin, Ph.D. Kaohsiung Veterans General Hospital.
Principal Investigator: Salvatore Giovanni Vitale, M.D. University of Messina

Publications:

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Responsible Party: Li-Te Lin, Visiting Staff, Department of Obstetrics and Gynecology, Principal Investigator, Clinical Lecturer, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT03438812     History of Changes
Other Study ID Numbers: VGHKS14-CT10-16
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs