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

Sponsor
Lucy Coleman (Industry)
Overall Status
Completed
CT.gov ID
NCT03621683
Collaborator
(none)
78
1
2
19.7
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: blood rich plasma platelets
  • Dietary Supplement: Antioxidant therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective comparative studyProspective comparative study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Actual Study Start Date :
Jan 6, 2016
Actual Primary Completion Date :
Jan 10, 2017
Actual Study Completion Date :
Aug 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: ovarian bio-stimulation

Intervention: ovarian bio-stimulation: blood rich plasma platelets

Procedure: blood rich plasma platelets
Injection of blood rich platelet into the ovaries.

Dietary Supplement: Antioxidant therapy
Antioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3

Active Comparator: Antioxidant therapy

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

Procedure: blood rich plasma platelets
Injection of blood rich platelet into the ovaries.

Dietary Supplement: Antioxidant therapy
Antioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3

Outcome Measures

Primary Outcome Measures

  1. variation of hormones FSH and LH directly involved with ovarian reserve [18 months]

    Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with FSH-LH post-treatment.

  2. variation of AMH directly involved with ovarian reserve in both groups [18 months]

    Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with AMH values.

  3. variation in recruitment of antral follicles in both groups [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.

Secondary Outcome Measures

  1. Number of good quality eggs obtained in both groups after IVF [18 months]

    Egg quality is evaluated in both group of women undergoing IVF after bio-stimulation or antioxidant therapy are performed

  2. Number and quality of fertilised eggs obtained in both groups after IVF [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Years to 46 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fertiaguerrevere Fertility Caracas Disfrito Federal Venezuela 1018

Sponsors and Collaborators

  • Lucy Coleman

Investigators

  • Principal Investigator: Carmen Navarro, MD, Medical staff

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lucy Coleman, Scientific director, Fertiaguerrevere
ClinicalTrials.gov Identifier:
NCT03621683
Other Study ID Numbers:
  • J298384255
First Posted:
Aug 8, 2018
Last Update Posted:
Aug 8, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2018