- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621683
Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Disfrito Federal
-
Caracas, Disfrito Federal, Venezuela, 1018
- Fertiaguerrevere Fertility
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ovarian bio-stimulation
Intervention: ovarian bio-stimulation: blood rich plasma platelets |
Injection of blood rich platelet into the ovaries.
Antioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3 |
ACTIVE_COMPARATOR: Antioxidant therapy
Intervention: antioxidants: Q10, DHEA, Vitamin E, Vitamin C, omega 3 |
Injection of blood rich platelet into the ovaries.
Antioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
variation of hormones FSH and LH directly involved with ovarian reserve
Time Frame: 18 months
|
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with FSH-LH post-treatment.
|
18 months
|
variation of AMH directly involved with ovarian reserve in both groups
Time Frame: 18 months
|
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with AMH values.
|
18 months
|
variation in recruitment of antral follicles in both groups
Time Frame: 18 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of good quality eggs obtained in both groups after IVF
Time Frame: 18 months
|
Egg quality is evaluated in both group of women undergoing IVF after bio-stimulation or antioxidant therapy are performed
|
18 months
|
Number and quality of fertilised eggs obtained in both groups after IVF
Time Frame: 18 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carmen Navarro, MD, Medical staff
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: Nature. 2004 Aug 26;430(7003):1062.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J298384255
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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