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

Study Overview
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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.

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

Conditions
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Ovarian Reserve

Intervention / Treatment
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* Procedure: blood rich plasma platelets
* Dietary Supplement: Antioxidant therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective comparative study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ovarian bio-stimulation<br>Intervention: ovarian bio-stimulation: blood rich plasma platelets | Procedure: blood rich plasma platelets<br>* Injection of blood rich platelet into the ovaries.<br>Dietary Supplement: Antioxidant therapy<br>* Antioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3<br>|
| Active Comparator: Antioxidant therapy<br>Intervention: antioxidants: Q10, DHEA, Vitamin E, Vitamin C, omega 3 | Procedure: blood rich plasma platelets<br>* Injection of blood rich platelet into the ovaries.<br>Dietary Supplement: Antioxidant therapy<br>* Antioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of good quality eggs obtained in both groups after IVF | 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 | 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 |