Stem Cell Therapy and Growth Factor Ovarian in Vitro Activation

NCT04009473 | Unknown Phase 1 FDA Device

• 1 other identifier: IRB No 63/295/2015
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

SEGOVA procedure includes - Stem cell therapy, G - Growth factor Platelet Plasma Rich therapy and in Vitro Activation of the ovaries.

Conditions

Menopause; Menopause Ovarian Failure; Ovarian Failure; Premature Ovarian Failure; Premature Ovarian Failure 1; Premature Ovarian Failure 2A; Premature Ovarian Failure 2B; Premature Ovarian Failure 3; Premature Ovarian Failure 4; Premature Ovarian Failure 5; Premature Ovarian Failure 6; Premature Ovarian Failure 7; Premature Ovarian Failure 8; Premature Ovarian Failure 9; Premature Ovarian Failure 10; Premature Ovarian Failure 11; Premature Ovarian Failure 12; Premature Ovarian Failure 13; Premature Ovarian Failure 14; Ovarian Insufficiency; Ovarian Failure Secondary; Ovarian Failure, Premature; Ovarian Insufficiency, Primary; Menopause, Premature

Keywords

platelet rich plasma; growth factors; stem cells; bone marrow; in vitro activation; ovarian cortex transplantation; hippo signalling pathway

Outcome Measures

Primary Outcomes (5)

• Oocyte presence

  The numbers of oocytes retrieved after the treatment would be monitored during sonographic follow-ups .

  12 months

• Changes in Hormone Levels of Follicle-stimulating hormone FSH (mIU/mL)

  Changes in hormonal levels of FSH toward normal ranges would be monitored during one year follow-up procedure.

  12 months

• Changes in Hormone Levels of Luteinizing Hormone (mIU/mL)

  Changes in hormonal levels of LH toward normal ranges would be monitored during one year follow-up procedure.

  12

• Changes in Hormone Levels of Estradiol E2 (pg/mL)

  Changes in hormonal levels of E2 toward normal ranges would be monitored during one year follow-up procedure.

  12

• Changes in Hormone Levels of Progesterone PG (ng/mL)

  Changes in hormonal levels of PG toward normal ranges would be monitored during one year follow-up procedure.

  6

Secondary Outcomes (4)

• Fertilization and implantation rate

  12 months

• Number of participants with Positive Clinical Pregnancy

  24 months

• Changes in total score of The World Health Organization Quality of Life (WHOQOL) BREF modified scale

  12 months

• Changes in anti-Mullerian hormone (AMH) levels (ng/mL)

  6 months

Study Arms (1)

SEGOVA Intervention Group

EXPERIMENTAL

Intervention group of 50-100 patients with ovarian failure would be subjected to a three-day procedure named SEGOVA: bone marrow derived StEm cell treatment, Growth factor incubation and Ovarian In Vitro Activation. After the procedure, one year follow up of hormones measurements (follicle stimulating hormone (FSH), luteinizing hormone (LH),estradiol (E2), progesterone (PG) and anti-mullerian hormone (AMH)) and follicle counts would be established. In patients with oocytes retrieved after SEGOVA procedure, standard In Vitro Fertilization protocol would be performed. The fertilization, cleavage and clinical pregnancy rate will be monitored.

Combination Product: SEGOVA procedure

Interventions

SEGOVA procedure COMBINATION_PRODUCT

SEGOVA procedure includes - Stem cell therapy, G - Growth factor Platelet Plasma Rich therapy and in Vitro Activation of the ovaries.

SEGOVA Intervention Group

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: The eligible patients are women with at least one ovary present.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed informed consent, signature and date
• A woman over 25 years of age
• Primary or secondary amenorrhea for at least 3 months
• Hormone Anti Mullerian Hormone values \<\_0.42 ng / ML and Follicle stimulating hormone FSH\> 20 IU / L, and / or failure of previous attempts of assisted reproductive techniques due to limited ovarian response (less than 3 oocyte cells obtained).
• The proper karyotype 46, XX.
• Presence of at least one ovary

You may not qualify if:

• Currently pregnancy or breastfeeding
• Presence of Sexually Transmitted Disease (STD positive)
• There is presence of acute infection (C Reactive Protein\>5)
• There is an anamnesis or evidence of existing gynecological malignancy
• The presence of adnexal masses indicating the need for further evaluation.
• It has a contraindication to laparoscopic surgery and / or general anesthesia
• Over the past two weeks, use of the following medicines: Oral or systemic corticosteroids, hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with potential hormonal effects.
• Type I diabetes mellitus
• Known significant anemia (hemoglobin \<8 g / dL), Severe venous thrombosis and / or pulmonary embolism, Cerebrovascular disease, Presence of heart disease, Premature kidney disease (defined as urea in the blood\> 30 mg / dL or serum creatinine\> 1.6 mg / dL).

Sponsors & Collaborators

• Forever Young d.o.o.: lead
• Medigroup Health System, Jevremova hospital: collaborator
• Saint James Hospital Malta: collaborator
• Re-medika Hospital Skoplje: collaborator

Study Sites (3)

Saint James Hospital Malta

Sliema, SLM 3011, Malta

Location

Re-medika Hospital

Skopje, Macedonia, 1000, North Macedonia

Location

Medigroup Health System, Jevremova hospital

Belgrade, 11000, Serbia

Location

Related Publications (1)

• Tinjic S, Abazovic D, Ljubic D, Vojvodic D, Bozanovic T, Ibrisimovic M, Markovic S, Ljubic A. Influence of Autologous In Vitro Activation of Ovaries by Stem Cells and Growth Factors on Endocrine and Reproductive Function of Patients with Ovarian Insufficiency-A Clinical Trial Study. Int J Fertil Steril. 2021 Jul;15(3):178-188. doi: 10.22074/IJFS.2020.134678. Epub 2021 Jun 22.

  PMID: 34155864 DERIVED

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Premature Ovarian Failure 2a; Premature Ovarian Failure 2b; Premature Ovarian Failure 3; Ovarian Dysgenesis 2; Premature Ovarian Failure 5; Premature Ovarian Failure 6; Premature Ovarian Failure 7; Menopause, Premature

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Aleksandar Ljubic, MD, PhD

  Medigroup, Belgrade, Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post study design: A study group receives the intervention, and the changes in parameters were measured and compared before and after the intervention.

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 5, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Draft study protocol and Statistical Analysis Plan are available entire duration of the study. Informed Consent Forms would be available upon study completion date.
• Access Criteria: Access to any additional supporting information about the protocol description or methods used to collect the data will be shared if required by other research organisations. Request would be reviewed by Principal Investigator.

Locations

NO (1); SE (1); MA (1)