Effectiveness of Adjuvant Supplements Prior to in IVF

Dietary Supplements Clinical Trial

Official title:

To Investigate the Effectiveness of Adjuvant Supplements Prior to in Vitro Fertilization Cycles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471453
• Other study ID #: KSVGH21-CT8-13
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Kaohsiung Veterans General Hospital.
• Contact: Li-Te Lin
• Phone: +88673464027
• Email: litelin1982[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 44 Years

Eligibility

Inclusion Criteria:

• Age 35~44

• BMI18~30 kg/m2

• Diminished ovarian reserve (AFC<5, AMH<1.2 ng/ml)

Exclusion Criteria:

• Primary ovarian insufficiency

• Congenital uterine anomaly

• Severe intrauterine adhesion

• Severe male factor

• Chromosome anomaly

• Malignancy

• Donor cycle

• having supplementation within 3 months

Related Conditions & MeSH terms

• Dietary Supplements

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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

Labrie F, Martel C, Bélanger 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. Review. — View Citation

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. Review. — View Citation

Mohd Mutalip SS, Ab-Rahim S, Rajikin MH. Vitamin E as an Antioxidant in Female Reproductive Health. Antioxidants (Basel). 2018 Jan 26;7(2). pii: E22. doi: 10.3390/antiox7020022. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical pregnancy rate	the presence of a fetal heartbeat at 6-7 weeks of a pregnancy	through study completion, an average of 1.75 year
Secondary	mitochondrial function of cumulus cells	Oxygen consumption rate of cumulus cells	through study completion, an average of 1.75 year