Clinical trial NCT03621683: Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Official title: Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Reserve
Lead sponsor: Fertiaguerrevere
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 78
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective comparative study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: variation of hormones FSH and LH directly involved with ovarian reserve
timeFrame: 18 months
measure: variation of AMH directly involved with ovarian reserve in both groups
timeFrame: 18 months
measure: variation in recruitment of antral follicles in both groups
timeFrame: 18 months
Secondary outcomes:
measure: Number of good quality eggs obtained in both groups after IVF
timeFrame: 18 months
measure: Number and quality of fertilised eggs obtained in both groups after IVF
timeFrame: 18 months
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Fertiaguerrevere Fertility
state: Disfrito Federal
Study officials:
affiliation: Medical staff
name: Carmen Navarro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Nov 9.
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. doi: 10.1186/1477-7827-2-24. No abstract available.
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. doi: 10.1038/nature02316.
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.
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.
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 IN ENDOCRINOLOGY: Aging and anti-aging: a Combo-Endocrinology overview. Eur J Endocrinol. 2017 Jun;176(6):R283-R308. doi: 10.1530/EJE-16-1061. Epub 2017 Mar 6.
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 2016 Feb 1.
citation: Ozcan P, Ficicioglu 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 Jun 3.