Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women

• Sponsor: Genesis Athens Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03916978
• Collaborator: National and Kapodistrian University of Athens (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 56.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female; Anovulatory Infertility; Menopause; Amenorrhea	Biological: Autologous PRP intra ovarian infusion; Biological: Autologous PFP intra ovarian infusion	Phase 2/Phase 3

Detailed Description

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to menopausal women. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in menopausal women.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women
• Actual Study Start Date: May 21, 2019
• Anticipated Primary Completion Date: Jan 30, 2024
• Anticipated Study Completion Date: Jan 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants receiving PRP treatment Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.	Biological: Autologous PRP intra ovarian infusion; Autologous PRP intra ovarian infusion
Placebo Comparator: Control Group: Participants receiving Platelet Free Plasma Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.	Biological: Autologous PFP intra ovarian infusion; Autologous PFP intra ovarian infusion

Outcome Measures

Primary Outcome Measures

1. Restoration of menstrual cycle [Three months]

   Menstrual cycle restoration

2. Serum FSH levels [Follow-up period of three months entailing monthly evaluation]

   Serum FSH levels evaluated monthly for three consecutive months.

Secondary Outcome Measures

1. Serum AMH levels [Follow-up period of three months entailing monthly evaluation]

   Serum AMH levels evaluated monthly for three consecutive months.

2. Serum estradiol levels [Follow-up period of three months entailing monthly evaluation]

   Serum estradiol levels evaluated monthly for three consecutive months.

3. Serum LH levels [Follow-up period of three months entailing monthly evaluation]

   Serum LH levels evaluated monthly for three consecutive months.

4. Serum progesterone levels [Follow-up period of three months entailing monthly evaluation]

   Serum progesterone levels evaluated monthly for three consecutive months.

5. Antral Follicle Count [Follow-up period of three months entailing monthly evaluation]

   AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age between 45-55 years old

• Amenorrhea for at least 12 months

• Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.

• Willing to comply with study requirements

Exclusion Criteria:

• Any pathological disorder related to reproductive system anatomy

• Previous POI diagnosis

• Abnormal karyotype

• Endometriosis

• Adenomyosis

• Fibroids and adhesions

• Infections in reproductive system

• Current or previous diagnosis of reproductive system cancer

• History of familiar cancer in reproductive system

• Severe male factor infertility

• Prior referral for PGT

• Ovarian inaccessibility

• Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)

• BMI>30 kg/m2 or BMI<18.5 kg/m2

• Systematic autoimmune disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genesis AC	Athens		Greece	15232

Sponsors and Collaborators

• Genesis Athens Clinic
• National and Kapodistrian University of Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genesis Athens Clinic
• ClinicalTrials.gov Identifier: NCT03916978
• Other Study ID Numbers: PRP - Menopausal women
• First Posted: Apr 16, 2019
• Last Update Posted: Dec 14, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Genesis Athens Clinic: Ovarian rejuvenation; Ovarian reactivation; ovulation
• Additional relevant MeSH terms: Infertility; Infertility, Female; Amenorrhea

Study Results

No Results Posted as of Dec 14, 2021