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

August 3, 2018 updated by: Lucy Coleman

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

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
    • Disfrito Federal
      • Caracas, Disfrito Federal, Venezuela, 1018
        • Fertiaguerrevere Fertility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 46 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Lucy Coleman

Investigators

  • Principal Investigator: Carmen Navarro, MD, Medical staff

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 6, 2016

Primary Completion (ACTUAL)

January 10, 2017

Study Completion (ACTUAL)

August 28, 2017

Study Registration Dates

First Submitted

July 28, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (ACTUAL)

August 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

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)?

UNDECIDED

IPD Plan Description

Still deciding if sharing information. It can be shared as long as it does not contain personal identification such as name, and contact details. We might share the rest of information to other scientist studying the same area of low-depleted ovarian reserve and bio-stimulation techniques.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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