Ovarian Reserve Clinical Trial
Official title:
Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Verified date | August 2018 |
Source | Fertiaguerrevere |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Venezuela | Fertiaguerrevere Fertility | Caracas | Disfrito Federal |
Lead Sponsor | Collaborator |
---|---|
Lucy Coleman |
Venezuela,
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
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 |
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