Study Results
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Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2022-03-02
2023-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DHEA group
75 mg DHEA supplementation per day for 3 months before IVF
DHEA
75 mg DHEA supplementation per day for 3 months before IVF
DHEA+CoQ10+Tocotrienol group
75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF
DHEA+CoQ10+Tocotrienol
75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF
Control group
No supplementation before IVF
No interventions assigned to this group
Interventions
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DHEA
75 mg DHEA supplementation per day for 3 months before IVF
DHEA+CoQ10+Tocotrienol
75 mg DHEA supplementation + 30 mg CoQ10 + 300 mg Tocotrienol per day for 3 months before IVF
Eligibility Criteria
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Inclusion Criteria
* BMI18\~30 kg/m2
* Diminished ovarian reserve (AFC\<5, AMH\<1.2 ng/ml)
Exclusion Criteria
* Congenital uterine anomaly
* Severe intrauterine adhesion
* Severe male factor
* Chromosome anomaly
* Malignancy
* Donor cycle
* having supplementation within 3 months
35 Years
44 Years
FEMALE
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Li-Te Lin
Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Assistant professor
Principal Investigators
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Kuan-Hao Tsui
Role: STUDY_DIRECTOR
Kaohsiung Veterans General Hospital.
Locations
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Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
Kaohsiung City, , Taiwan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KSVGH21-CT8-13
Identifier Type: -
Identifier Source: org_study_id
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