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

Not Applicable

Completed

• Conditions: Ovarian Reserve
• Interventions: Procedure: blood rich plasma platelets; Dietary Supplement: Antioxidant therapy

• Registration Number: NCT03621683
• Lead Sponsor: Lucy Coleman

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 Timeline

• Study Start: 2016-01-06
• Primary Completion: 2017-01-10
• Study Completion: 2017-08-28
• Study First Submitted: 2018-07-28
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-03
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ovarian bio-stimulation	Antioxidant therapy	Intervention: ovarian bio-stimulation: blood rich plasma platelets
Antioxidant therapy	blood rich plasma platelets	Intervention: antioxidants: Q10, DHEA, Vitamin E, Vitamin C, omega 3
ovarian bio-stimulation	blood rich plasma platelets	Intervention: ovarian bio-stimulation: blood rich plasma platelets
Antioxidant therapy	Antioxidant therapy	Intervention: antioxidants: Q10, DHEA, Vitamin E, Vitamin C, omega 3

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Fertiaguerrevere Fertility; 🇻🇪 Caracas, Disfrito Federal, Venezuela