Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- variation of hormones FSH and LH directly involved with ovarian reserve
Study Overview
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.
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
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 38 Years to 46 Years (Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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.
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.
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
- 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)
Investigators
Lucy Coleman
Scientific director
Fertiaguerrevere