Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?

NCT04381299 | Active Not Recruiting DMC

• 1 other identifier: 2004-ABU-003-LM
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A-PRP (Autologous Platelet Rich Plasma) is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This study will involve adult women with a diagnosis of Premature ovarian insufficiency (POI) willing to perform an IVF/ICSI treatment.

Conditions

Infertility; IVF; Premature Ovarian Failure; Anti-Mullerian Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Appearance of new ovarian follicles (number of follicles growing) with evidence of estradiol production.

  Evaluate the difference of number of follicles growing, means values will be calculated at the two points time (baseline and 12 weeks). Means differences will be verified using the t test analysis (after confirming the normal distribution of the data by means of Kolmogorov-Smirnoff tests. If normal distribution is not confirmed a non-parametric anova test will be used. This rule will be applied to all analysis

  12 weeks

Secondary Outcomes (4)

• Increase in serum AMH above the baseline level

  12 weeks

• Increase in AFC above the baseline level in 12 weeks

  12 weeks

• Total number of retrieved oocytes in an IVF cycle.

  1 day

• Pregnancy rates

  40 weeks

Study Arms (2)

Intervention

The cortex of selected ovary will be injected with 1 mL of autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.

Other: autologous platelet rich plasma

Control

The cortex of contralateral ovary will be injected with 1 mL of saline solution (SS). Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.

Other: saline solution

Interventions

autologous platelet rich plasma OTHER

The cortex of selected ovary will be injected with 1 mL of autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.

Intervention

saline solution OTHER

The cortex of contralateral ovary will be injected with 1 mL of saline solution (SS). Up to ten different sites will be injected under ultrasound guidance. In the surgical report, the surgeon will state how many punctures have been done.

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment.

You may qualify if:

• Signed and dated informed consent
• Women 40 years of age and younger with documented primary ovarian insufficiency (12).
• Normal Karyotype
• BMI \</= 35 kg/m2
• Oligo/amenorrhea for at least 4 months
• FSH \> 25 IU/mL
• AMH \</= 0,1 ng/ml
• No evidence of follicles \> 4mm
• Must have two ovaries of approximately equal volume.
• Willingness to undergo further fertility treatment, including IVF if there is evidence of response
• A transvaginal scan including Doppler for arteria ovarica will be performed previously to the surgical procedure.

You may not qualify if:

• Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality.
• Oncological diseases (specially, skeletal system and blood).
• Autoimmune diseases, for example, lupus erythematosus, etc.
• Previous treatments including radiotherapy or chemotherapy.
• Other conditions not suitable for surgical procedures and/or anesthesia.
• Anticoagulant or antiaggregant treatment.
• Acute and chronic infectious diseases.
• Active substance abuse or dependence.
• Major Mental health disorder.

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

Location

Related Publications (11)

• Ford EA, Beckett EL, Roman SD, McLaughlin EA, Sutherland JM. Advances in human primordial follicle activation and premature ovarian insufficiency. Reproduction. 2020 Jan;159(1):R15-R29. doi: 10.1530/REP-19-0201.

  PMID: 31376814 BACKGROUND

• Zhang X, Han T, Yan L, Jiao X, Qin Y, Chen ZJ. Resumption of Ovarian Function After Ovarian Biopsy/Scratch in Patients With Premature Ovarian Insufficiency. Reprod Sci. 2019 Feb;26(2):207-213. doi: 10.1177/1933719118818906. Epub 2018 Dec 12.

  PMID: 30541396 BACKGROUND

• Kawamura K, Kawamura N, Hsueh AJ. Activation of dormant follicles: a new treatment for premature ovarian failure? Curr Opin Obstet Gynecol. 2016 Jun;28(3):217-22. doi: 10.1097/GCO.0000000000000268.

  PMID: 27022685 BACKGROUND

• Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.

  PMID: 21479340 BACKGROUND

• Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039.

  PMID: 18480812 BACKGROUND

• Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.

  PMID: 20351977 BACKGROUND

• Sfakianoudis K, Simopoulou M, Nitsos N, Rapani A, Pantou A, Vaxevanoglou T, Kokkali G, Koutsilieris M, Pantos K. A Case Series on Platelet-Rich Plasma Revolutionary Management of Poor Responder Patients. Gynecol Obstet Invest. 2019;84(1):99-106. doi: 10.1159/000491697. Epub 2018 Aug 22.

  PMID: 30134239 BACKGROUND

• Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.

  PMID: 29486615 BACKGROUND

• Sills ES, Li X, Rickers NS, Wood SH, Palermo GD. Metabolic and neurobehavioral response following intraovarian administration of autologous activated platelet rich plasma: First qualitative data. Neuro Endocrinol Lett. 2019 Jan;39(6):427-433.

  PMID: 30796792 BACKGROUND

• Sills ES, Rickers NS, Svid CS, Rickers JM, Wood SH. Normalized Ploidy Following 20 Consecutive Blastocysts with Chromosomal Error: Healthy 46, XY Pregnancy with IVF after Intraovarian Injection of Autologous Enriched Platelet-derived Growth Factors. Int J Mol Cell Med. 2019 Winter;8(1):84-90. doi: 10.22088/IJMCM.BUMS.8.1.84. Epub 2019 May 15.

  PMID: 32195207 BACKGROUND

• European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.

  PMID: 27008889 BACKGROUND

Related Links

• Ovarian rejuvenation and folliculogenesis reactivation in peri-menopausal women after autologous platelet-rich plasma treatment

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Infertility; Primary Ovarian Insufficiency

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Laura Melado, PhD

  ART Fertility Clinics LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: April 25, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-01

Locations

AE (1)