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OpenTrials
Completed

NCT Number: NCT03621683

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.

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Key information

Conditions

Ovarian Reserve

Age range

38 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertiaguerrevere Fertility

Caracas, Disfrito Federal, 1018, Venezuela

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood rich plasma platelets

Procedure

Injection of blood rich platelet into the ovaries.

Antioxidant therapy

Dietary Supplement

Antioxidants:

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Lucy Coleman

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2018
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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