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

NCT ID: NCT03621683

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-06

Study Completion Date

2017-08-28

Brief Summary

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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

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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.

Conditions

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Ovarian Reserve

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective comparative study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ovarian bio-stimulation

Intervention:

ovarian bio-stimulation: blood rich plasma platelets

Group Type EXPERIMENTAL

blood rich plasma platelets

Intervention Type PROCEDURE

Injection of blood rich platelet into the ovaries.

Antioxidant therapy

Intervention Type DIETARY_SUPPLEMENT

Antioxidants:

Q10, DHEA, Vitamina E, Vitamin C, Omega 3

Antioxidant therapy

Intervention:

antioxidants: Q10, DHEA, Vitamin E, Vitamin C, omega 3

Group Type ACTIVE_COMPARATOR

blood rich plasma platelets

Intervention Type PROCEDURE

Injection of blood rich platelet into the ovaries.

Antioxidant therapy

Intervention Type DIETARY_SUPPLEMENT

Antioxidants:

Q10, DHEA, Vitamina E, Vitamin C, Omega 3

Interventions

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blood rich plasma platelets

Injection of blood rich platelet into the ovaries.

Intervention Type PROCEDURE

Antioxidant therapy

Antioxidants:

Q10, DHEA, Vitamina E, Vitamin C, Omega 3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

38 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lucy Coleman

INDUSTRY

Sponsor Role lead

Responsible Party

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Lucy Coleman

Scientific director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carmen Navarro, MD

Role: PRINCIPAL_INVESTIGATOR

Medical staff

Locations

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Fertiaguerrevere Fertility

Caracas, Disfrito Federal, Venezuela

Site Status

Countries

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Venezuela

References

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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.

Reference Type RESULT
PMID: 26635884 (View on PubMed)

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.

Reference Type RESULT
PMID: 15149546 (View on PubMed)

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.

Reference Type RESULT
PMID: 15014492 (View on PubMed)

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.

Reference Type RESULT
PMID: 26788065 (View on PubMed)

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.

Reference Type RESULT
PMID: 26029346 (View on PubMed)

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.

Reference Type RESULT
PMID: 28264815 (View on PubMed)

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.

Reference Type RESULT
PMID: 26829445 (View on PubMed)

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.

Reference Type RESULT
PMID: 27255570 (View on PubMed)

Other Identifiers

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J298384255

Identifier Type: -

Identifier Source: org_study_id

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