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Poor RespondersNCT03438812

Dehydroepiandrosterone Maintain Mitochondrial Quality of Cumulus Cells in Poor Ovarian Responders

A study testing dehydroepiandrosterone (DHEA) in people with Poor Responders and Dehydroepiandrosterone, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate whether the DHEA supplementation could improve mitochondrial quality in poor ovarian responders Read more about this study

Who is it for?
Ages 25 to 45 years, women only
Conditions the study is for
Poor Responders, Dehydroepiandrosterone
What is being tested?
dehydroepiandrosterone (DHEA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTaiwan
Study dates
6 Sep 2017to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

Other trials in Taiwan

About this study

Official title: 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

Read the 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.

Being tested
dehydroepiandrosterone (DHEA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dehydroepiandrosterone (DHEA)Dietary supplement

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

Study groups in NCT03438812
Study groupRoleWhat they receive
Poor ovarian responders with DHEAExperimentalWomen who meet the Bologna criteria receive dehydroepiandrosterone (DHEA, 90 mg daily for two months at least) supplementation prior to the IVF cycle.
Receives: Dietary Supplement: dehydroepiandrosterone (DHEA)
Poor ovarian respondersNo interventionWomen who meet the Bologna criteria undergo the IVF cycle without pretreatment with DHEA
Normal ovarian respondersNo interventionWomen who do not meet the Bologna criteria and have normal ovarian response to ovarian stimulation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mitochondria related genes expression

    cumulus cells genes expression

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. oocytes

    retrieved oocytes in number

    Measured: through study completion, an average of 1 year

  2. embryos

    day 3 embryos in number

    Measured: numbers will be confirmed 3 days after fertilization

  3. pregnancy rate

    clinical pregnancy rate

    Measured: pregnancy will be confirmed 4 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2018
  2. Study start6 Sep 2017
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03438812
Sponsor's protocol ID
VGHKS14-CT10-16
Status last verified
Feb 2021
First submitted
4 Feb 2018
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

    PubMed 21505041

  • Lin LT, Tsui KH, Wang PH. Clinical application of dehydroepiandrosterone in reproduction: A review of the evidence. J Chin Med Assoc. 2015 Aug;78(8):446-53. doi: 10.1016/j.jcma.2014.12.008. Epub 2015 Feb 20.

    PubMed 25708822

  • Zhang J, Qiu X, Gui Y, Xu Y, Li D, Wang L. Dehydroepiandrosterone improves the ovarian reserve of women with diminished ovarian reserve and is a potential regulator of the immune response in the ovaries. Biosci Trends. 2015 Dec;9(6):350-9. doi: 10.5582/bst.2015.01154.

    PubMed 26781792

  • Nagels HE, Rishworth JR, Siristatidis CS, Kroon B. Androgens (dehydroepiandrosterone or testosterone) for women undergoing assisted reproduction. Cochrane Database Syst Rev. 2015 Nov 26;2015(11):CD009749. doi: 10.1002/14651858.CD009749.pub2.

    PubMed 26608695

  • Tsui KH, Lin LT, Horng HC, Chang R, Huang BS, Cheng JT, Wang PH. Gene expression of cumulus cells in women with poor ovarian response after dehydroepiandrosterone supplementation. Taiwan J Obstet Gynecol. 2014 Dec;53(4):559-65. doi: 10.1016/j.tjog.2014.09.003.

    PubMed 25510701

  • Lin LT, Wang PH, Chen SN, Li CJ, Wen ZH, Cheng JT, Tsui KH. Protection of cumulus cells following dehydroepiandrosterone supplementation. Gynecol Endocrinol. 2017 Feb;33(2):100-104. doi: 10.1080/09513590.2016.1214262. Epub 2016 Aug 12.

    PubMed 27684542

  • Santos TA, El Shourbagy S, St John JC. Mitochondrial content reflects oocyte variability and fertilization outcome. Fertil Steril. 2006 Mar;85(3):584-91. doi: 10.1016/j.fertnstert.2005.09.017.

    PubMed 16500323

  • Zeng HT, Ren Z, Yeung WS, Shu YM, Xu YW, Zhuang GL, Liang XY. Low mitochondrial DNA and ATP contents contribute to the absence of birefringent spindle imaged with PolScope in in vitro matured human oocytes. Hum Reprod. 2007 Jun;22(6):1681-6. doi: 10.1093/humrep/dem070. Epub 2007 Apr 20.

    PubMed 17449512

  • Lee SK, Zhao MH, Kwon JW, Li YH, Lin ZL, Jin YX, Kim NH, Cui XS. The association of mitochondrial potential and copy number with pig oocyte maturation and developmental potential. J Reprod Dev. 2014 Apr 24;60(2):128-35. doi: 10.1262/jrd.2013-098. Epub 2014 Feb 4.

    PubMed 24492657

  • Zhang M, Niu W, Wang Y, Xu J, Bao X, Wang L, Du L, Sun Y. Dehydroepiandrosterone treatment in women with poor ovarian response undergoing IVF or ICSI: a systematic review and meta-analysis. J Assist Reprod Genet. 2016 Aug;33(8):981-91. doi: 10.1007/s10815-016-0713-5. Epub 2016 Apr 19.

    PubMed 27094195

  • Alexaki VI, Charalampopoulos I, Panayotopoulou M, Kampa M, Gravanis A, Castanas E. Dehydroepiandrosterone protects human keratinocytes against apoptosis through membrane binding sites. Exp Cell Res. 2009 Aug 1;315(13):2275-83. doi: 10.1016/j.yexcr.2009.04.006. Epub 2009 Apr 18.

    PubMed 19379733

  • Liu D, Si H, Reynolds KA, Zhen W, Jia Z, Dillon JS. Dehydroepiandrosterone protects vascular endothelial cells against apoptosis through a Galphai protein-dependent activation of phosphatidylinositol 3-kinase/Akt and regulation of antiapoptotic Bcl-2 expression. Endocrinology. 2007 Jul;148(7):3068-76. doi: 10.1210/en.2006-1378. Epub 2007 Mar 29.

    PubMed 17395704

  • Charalampopoulos I, Tsatsanis C, Dermitzaki E, Alexaki VI, Castanas E, Margioris AN, Gravanis A. Dehydroepiandrosterone and allopregnanolone protect sympathoadrenal medulla cells against apoptosis via antiapoptotic Bcl-2 proteins. Proc Natl Acad Sci U S A. 2004 May 25;101(21):8209-14. doi: 10.1073/pnas.0306631101. Epub 2004 May 17.

    PubMed 15148390

  • Ding X, Wang D, Li L, Ma H. Dehydroepiandrosterone ameliorates H2O2-induced Leydig cells oxidation damage and apoptosis through inhibition of ROS production and activation of PI3K/Akt pathways. Int J Biochem Cell Biol. 2016 Jan;70:126-39. doi: 10.1016/j.biocel.2015.11.018. Epub 2015 Nov 28.

    PubMed 26643608

  • Patel MA, Katyare SS. Effect of dehydroepiandrosterone (DHEA) treatment on oxidative energy metabolism in rat liver and brain mitochondria. A dose-response study. Clin Biochem. 2007 Jan;40(1-2):57-65. doi: 10.1016/j.clinbiochem.2006.08.014. Epub 2006 Sep 14.

    PubMed 17052700

Questions about this trial

What is this clinical trial studying?

A study testing dehydroepiandrosterone (DHEA) in people with Poor Responders and Dehydroepiandrosterone, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mitochondria related genes expression (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03438812, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

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