Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve

Ovarian Reserve Clinical Trial

Official title:

Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621683
• Other study ID #: J298384255
• Status: Completed
• Phase: N/A
• Start date: January 6, 2016
• Est. completion date: August 28, 2017

Study information

• Verified date: August 2018
• Source: Fertiaguerrevere
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two group of patients were selected. Group 1 represents 46 patients that received ovarian-biostimulation monthly for three months. Group 2 represents 32 patients that received antioxidant therapy daily for 3 months. Results are noted and analysed.

Both groups represent patients with procedures already ongoing, and with diagnosed poor or depleted ovarian reserve.

The analysis has been made to compare the efficacy of both procedures.

Description:

The bioestimulation group received a blood rich platelet therapy monthly for three months, with a technique developed by the laboratory. The second group of antioxidants received a combination of antioxidants monthly for three months. Both groups were compared to assess the results in terms of ovarian response (number of astral follicles, AMH levels, FSH, LH), and egg quality, embryo development, implantation rate, and successful pregnancy with healthy live birth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 28, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 38 Years to 46 Years

Eligibility

Inclusion Criteria:

• Age between 38 and 46 years

• FSH> 12 mIU

• Estradiol > 100 pg/ml

• AMH < 0.8 ng/mL

Exclusion Criteria:

• Pelvic inflammatory syndrome

• vaginal pathologies

• known history of hyperandrogenism

• diagnosed platelet disorders as adhesion

• aggregation

• disorder of thromboxane synthesis.

Related Conditions & MeSH terms

• Ovarian Reserve

Intervention

Procedure:
• blood rich plasma platelets
Injection of blood rich platelet into the ovaries.

Dietary Supplement:
• Antioxidant therapy
Antioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3

Locations

Country	Name	City	State
Venezuela	Fertiaguerrevere Fertility	Caracas	Disfrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Lucy Coleman

Country where clinical trial is conducted

Venezuela, 

References & Publications (8)

Bhartiya D, Parte S, Patel H, Sriraman K, Zaveri K, Hinduja I. Novel Action of FSH on Stem Cells in Adult Mammalian Ovary Induces Postnatal Oogenesis and Primordial Follicle Assembly. Stem Cells Int. 2016;2016:5096596. doi: 10.1155/2016/5096596. Epub 2015 — View Citation

Diamanti-Kandarakis E, Dattilo M, Macut D, Duntas L, Gonos ES, Goulis DG, Gantenbein CK, Kapetanou M, Koukkou E, Lambrinoudaki I, Michalaki M, Eftekhari-Nader S, Pasquali R, Peppa M, Tzanela M, Vassilatou E, Vryonidou A; COMBO ENDO TEAM: 2016. MECHANISMS — View Citation

Gat I, Blanco Mejia S, Balakier H, Librach CL, Claessens A, Ryan EA. The use of coenzyme Q10 and DHEA during IUI and IVF cycles in patients with decreased ovarian reserve. Gynecol Endocrinol. 2016 Jul;32(7):534-7. doi: 10.3109/09513590.2015.1137095. Epub — View Citation

Johnson J, Canning J, Kaneko T, Pru JK, Tilly JL. Germline stem cells and follicular renewal in the postnatal mammalian ovary. Nature. 2004 Mar 11;428(6979):145-50. Erratum in: Nature. 2004 Aug 26;430(7003):1062. — View Citation

Ozakpinar OB, Maurer AM, Ozsavci D. Ovarian stem cells: From basic to clinical applications. World J Stem Cells. 2015 May 26;7(4):757-68. doi: 10.4252/wjsc.v7.i4.757. Review. — View Citation

Özcan P, Fiçicioglu C, Kizilkale O, Yesiladali M, Tok OE, Ozkan F, Esrefoglu M. Can Coenzyme Q10 supplementation protect the ovarian reserve against oxidative damage? J Assist Reprod Genet. 2016 Sep;33(9):1223-30. doi: 10.1007/s10815-016-0751-z. Epub 2016 — View Citation

Pan Z, Sun M, Liang X, Li J, Zhou F, Zhong Z, Zheng Y. The Controversy, Challenges, and Potential Benefits of Putative Female Germline Stem Cells Research in Mammals. Stem Cells Int. 2016;2016:1728278. doi: 10.1155/2016/1728278. Epub 2015 Dec 15. Review. — View Citation

Telfer EE. Germline stem cells in the postnatal mammalian ovary: a phenomenon of prosimian primates and mice? Reprod Biol Endocrinol. 2004 May 18;2:24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of hormones FSH and LH directly involved with ovarian reserve	Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with FSH-LH post-treatment.	18 months
Primary	variation of AMH directly involved with ovarian reserve in both groups	Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with AMH values.	18 months
Primary	variation in recruitment of antral follicles in both groups	Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with the number of astral follicles available.	18 months
Secondary	Number of good quality eggs obtained in both groups after IVF	Egg quality is evaluated in both group of women undergoing IVF after bio-stimulation or antioxidant therapy are performed	18 months
Secondary	Number and quality of fertilised eggs obtained in both groups after IVF	the number and quality of fertilised eggs is evaluated in both groups of women undergoing IVF after bio-stimulation or antioxidant therapy is performed.	18 months