NCT05471453

Brief Summary

To investigate the effect of combined DHEA, CoQ10 and tocotrienol on IVF cycles in poor ovarian responders

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

March 8, 2022

Last Update Submit

August 1, 2024

Conditions

Dietary Supplements

Keywords

DHEACoQ10Tocotrienolpoor ovarian responderin vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

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

    through study completion, an average of 1.75 year

Secondary Outcomes (2)

  • Clinical pregnancy rate

    through study completion, an average of 1.75 year

  • mitochondrial function of cumulus cells

    through study completion, an average of 1.75 year

Study Arms (3)

DHEA group

SHAM COMPARATOR

75 mg DHEA supplementation per day for 3 months before IVF

Dietary Supplement: DHEA

DHEA+CoQ10+Tocotrienol group

EXPERIMENTAL

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

Dietary Supplement: DHEA+CoQ10+Tocotrienol

Control group

NO INTERVENTION

No supplementation before IVF

Interventions

DHEADIETARY_SUPPLEMENT

75 mg DHEA supplementation per day for 3 months before IVF

DHEA group
DHEA+CoQ10+TocotrienolDIETARY_SUPPLEMENT

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

DHEA+CoQ10+Tocotrienol group

Eligibility Criteria

Age35 Years - 44 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kaohsiung City, 886, Taiwan

Location

Related Publications (12)

  • 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.

    PMID: 21505041BACKGROUND

  • 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.

    PMID: 26921622BACKGROUND

  • 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.

    PMID: 28153489BACKGROUND

  • 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.

    PMID: 25708822BACKGROUND

  • 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.

    PMID: 26608695BACKGROUND

  • 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.

    PMID: 32045470BACKGROUND

  • 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.

    PMID: 29587861BACKGROUND

  • 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.

    PMID: 23462735BACKGROUND

  • 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.

    PMID: 19946227BACKGROUND

  • 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.

    PMID: 29373543BACKGROUND

  • 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.

    PMID: 29217815BACKGROUND

  • 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.

    PMID: 30461035BACKGROUND

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Kuan-Hao Tsui

    Kaohsiung Veterans General Hospital.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor

Study Record Dates

First Submitted

March 8, 2022

First Posted

July 22, 2022

Study Start

March 2, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 2, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)