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

NCT03621683 | Completed DMC

• 1 other identifier: J298384255
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Reserve

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Number of good quality eggs obtained in both groups after IVF

  18 months

• Number and quality of fertilised eggs obtained in both groups after IVF

  18 months

Study Arms (2)

ovarian bio-stimulation

EXPERIMENTAL

Intervention: ovarian bio-stimulation: blood rich plasma platelets

Procedure: blood rich plasma platelets; Dietary Supplement: Antioxidant therapy

Antioxidant therapy

ACTIVE COMPARATOR

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

Procedure: blood rich plasma platelets; Dietary Supplement: Antioxidant therapy

Interventions

blood rich plasma platelets PROCEDURE

Injection of blood rich platelet into the ovaries.

Antioxidant therapy; ovarian bio-stimulation

Antioxidant therapy DIETARY_SUPPLEMENT

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

Antioxidant therapy; ovarian bio-stimulation

Eligibility Criteria

• Age: 38 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 38 and 46 years
• FSH\> 12 mIU
• Estradiol \> 100 pg/ml
• AMH \< 0.8 ng/mL

You may not qualify if:

• Pelvic inflammatory syndrome
• vaginal pathologies
• known history of hyperandrogenism
• diagnosed platelet disorders as adhesion
• aggregation
• disorder of thromboxane synthesis.

Sponsors & Collaborators

• Lucy Coleman: lead

Study Sites (1)

Fertiaguerrevere Fertility

Caracas, Disfrito Federal, 1018, Venezuela

Location

Related 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 Nov 9.

  PMID: 26635884 RESULT

• 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.

  PMID: 15149546 RESULT

• 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.

  PMID: 15014492 RESULT

• 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.

  PMID: 26788065 RESULT

• 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.

  PMID: 26029346 RESULT

• 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.

  PMID: 28264815 RESULT

• 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.

  PMID: 26829445 RESULT

• 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.

  PMID: 27255570 RESULT

Study Officials

• Carmen Navarro, MD

  Medical staff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific director

Model Details: Prospective comparative study

Study Record Dates

• First Submitted: July 28, 2018
• First Posted: August 8, 2018
• Study Start: January 6, 2016
• Primary Completion: January 10, 2017
• Study Completion: August 28, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

VE (1)