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AzTrials

Dietary SupplementsNCT05471453

Effectiveness of Adjuvant Supplements Prior to in IVF

A study testing DHEA and DHEA+CoQ10+Tocotrienol in people with Dietary Supplements, 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 the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in poor ovarian responders Read more about this study

Who is it for?
Ages 35 to 44 years, women only
Conditions the study is for
Dietary Supplements
What is being tested?
DHEA and DHEA+CoQ10+Tocotrienol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteTaiwan
Study dates
2 Mar 2022to 31 Dec 2023
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 35 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 35~44
  • BMI18~30 kg/m2
  • Diminished ovarian reserve (AFC<5, AMH<1.2 ng/ml)

Who cannot join

  • Primary ovarian insufficiency
  • Congenital uterine anomaly
  • Severe intrauterine adhesion
  • Severe male factor
  • Chromosome anomaly
  • Malignancy
  • Donor cycle
  • having supplementation within 3 months

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

    Kaohsiung City, 886

Other trials in Taiwan

About this study

Official title: 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

Read the 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

Being tested
DHEA, DHEA+CoQ10+Tocotrienol
Keywords
DHEA, CoQ10, Tocotrienol, poor ovarian responder, in vitro fertilization

What participants receive

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

  • DHEADietary supplement

    75 mg DHEA supplementation per day for 3 months before IVF

  • DHEA+CoQ10+TocotrienolDietary supplement

    75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF

Study groups in NCT05471453
Study groupRoleWhat they receive
DHEA groupSham comparator75 mg DHEA supplementation per day for 3 months before IVF
Receives: Dietary Supplement: DHEA
DHEA+CoQ10+Tocotrienol groupExperimental75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF
Receives: Dietary Supplement: DHEA+CoQ10+Tocotrienol
Control groupNo interventionNo supplementation before IVF

What is being measured

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

  1. Ongoing pregnancy rate

    continuous presence of a fetal heartbeat over 12 weeks of a pregnancy

    Measured: through study completion, an average of 1.75 year

Secondary outcomes (2)

  1. Clinical pregnancy rate

    the presence of a fetal heartbeat at 6-7 weeks of a pregnancy

    Measured: through study completion, an average of 1.75 year

  2. mitochondrial function of cumulus cells

    Oxygen consumption rate of cumulus cells

    Measured: through study completion, an average of 1.75 year

Timeline

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

  1. First posted22 Jul 2022
  2. Study start2 Mar 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05471453
Sponsor's protocol ID
KSVGH21-CT8-13
Status last verified
Aug 2024
First submitted
8 Mar 2022
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

  • Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.

    PubMed 26921622

  • Labrie F, Martel C, Belanger A, Pelletier G. Androgens in women are essentially made from DHEA in each peripheral tissue according to intracrinology. J Steroid Biochem Mol Biol. 2017 Apr;168:9-18. doi: 10.1016/j.jsbmb.2016.12.007. Epub 2017 Jan 30.

    PubMed 28153489

  • 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

  • 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

  • Zhang Y, Zhang C, Shu J, Guo J, Chang HM, Leung PCK, Sheng JZ, Huang H. Adjuvant treatment strategies in ovarian stimulation for poor responders undergoing IVF: a systematic review and network meta-analysis. Hum Reprod Update. 2020 Feb 28;26(2):247-263. doi: 10.1093/humupd/dmz046.

    PubMed 32045470

  • Xu Y, Nisenblat V, Lu C, Li R, Qiao J, Zhen X, Wang S. Pretreatment with coenzyme Q10 improves ovarian response and embryo quality in low-prognosis young women with decreased ovarian reserve: a randomized controlled trial. Reprod Biol Endocrinol. 2018 Mar 27;16(1):29. doi: 10.1186/s12958-018-0343-0.

    PubMed 29587861

  • Kamsani YS, Rajikin MH, Mohamed Nor Khan NA, Abdul Satar N, Chatterjee A. Nicotine-induced cessation of embryonic development is reversed by gamma-tocotrienol in mice. Med Sci Monit Basic Res. 2013 Mar 6;19:87-92. doi: 10.12659/MSMBR.883822.

    PubMed 23462735

  • Rajikin MH, Latif ES, Mar MR, Mat Top AG, Mokhtar NM. Deleterious effects of nicotine on the ultrastructure of oocytes: role of gamma-tocotrienol. Med Sci Monit. 2009 Dec;15(12):BR378-83.

    PubMed 19946227

  • Mohd Mutalip SS, Ab-Rahim S, Rajikin MH. Vitamin E as an Antioxidant in Female Reproductive Health. Antioxidants (Basel). 2018 Jan 26;7(2):22. doi: 10.3390/antiox7020022.

    PubMed 29373543

  • Hamirah NK, Kamsani YS, Mohamed Nor Khan NA, Ab Rahim S, Rajikin MH. Effects of Nicotine and Tocotrienol-Rich Fraction Supplementation on Cytoskeletal Structures of Murine Pre-Implantation Embryos. Med Sci Monit Basic Res. 2017 Dec 8;23:373-379. doi: 10.12659/msmbr.905447.

    PubMed 29217815

  • Abd Aziz NAA, Chatterjee A, Chatterjee R, Durairajanayagam D. Tocotrienol-rich fraction supplementation prevents foetal loss in females mated with corticosterone-treated male Sprague-Dawley rats. Andrologia. 2019 Apr;51(3):e13199. doi: 10.1111/and.13199. Epub 2018 Nov 20.

    PubMed 30461035

Questions about this trial

What is this clinical trial studying?

A study testing DHEA and DHEA+CoQ10+Tocotrienol in people with Dietary Supplements, 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 3 inclusion and 8 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 2 Aug 2024. 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. Some participants in this study may receive a placebo. 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?

Ongoing pregnancy rate (time frame: through study completion, an average of 1.75 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 NCT05471453, which also lists 12 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 2 Aug 2024.

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