Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency

NCT04237909 | Completed

• 1 other identifier: ATADEK 2019/8-18
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.

Conditions

Premature Ovarian Failure; Diminished Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• Ovarian reserve parameters

  Number of participants with intraovarian injection of autologous PRP as assessed by blood hormone analysis and ultrasonographic antral follicle counts, change in serum FSH, AMH levels and number of antral follicle counts.

  6 months

Secondary Outcomes (1)

• Ovarian response to stimulation

  12 months

Other Outcomes (1)

• IVF outcomes

  15 months

Study Arms (1)

Ovarian Reserve

EXPERIMENTAL

Patients with diminished ovarian reserve or premature ovarian insufficiency

Biological: PRP injection into at least one ovary

Interventions

PRP injection into at least one ovary BIOLOGICAL

The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary using a 35 cm 17 G single lumen needle. The injection will be done underneath the ovarian cortex to the subcortical and stromal areas. Approximately 2-4cc of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30-40 minutes and also be discharged home on the same day.

Ovarian Reserve

Eligibility Criteria

• Age: 20 Years - 48 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a history of \>1 year infertility duration with at least one ovary, who fulfilled the ESHRE criteria,
• Patients diagnosed with POR based on Poseidon criteria and with a history of at least one prior failed IVF cycle

You may not qualify if:

• Presence of pregnancy,
• previous diagnosis of any malignancy,
• ovarian insufficiency secondary to sex chromosome etiology,
• prior major lower abdominal surgery resulting in pelvic adhesions,
• anticoagulant use for which plasma infusion is contraindicated,
• current or previous (Immunoglobulin A (IgA) deficiency

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (5)

• Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.

  PMID: 26921622 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

• Leijdekkers JA, Eijkemans MJC, van Tilborg TC, Oudshoorn SC, van Golde RJT, Hoek A, Lambalk CB, de Bruin JP, Fleischer K, Mochtar MH, Kuchenbecker WKH, Laven JSE, Mol BWJ, Torrance HL, Broekmans FJM; OPTIMIST study group. Cumulative live birth rates in low-prognosis women. Hum Reprod. 2019 Jun 4;34(6):1030-1041. doi: 10.1093/humrep/dez051.

  PMID: 31125412 RESULT

• 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 RESULT

• Sfakianoudis K, Simopoulou M, Nitsos N, Lazaros L, Rapani A, Pantou A, Koutsilieris M, Nikas Y, Pantos K. Successful Implantation and Live Birth Following Autologous Platelet-rich Plasma Treatment for a Patient with Recurrent Implantation Failure and Chronic Endometritis. In Vivo. 2019 Mar-Apr;33(2):515-521. doi: 10.21873/invivo.11504.

  PMID: 30804135 RESULT

MeSH Terms

Conditions

Primary Ovarian Insufficiency

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

• Yigit Cakiroglu, Assoc.Prof.

  Acibadem University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: After the couples are recruited for the study, Antral follicle count (AFC), serum anti-mullerian hormone (AMH) and follicle stimulating hormone (FSH) levels will be determined at baseline and will be repeated beginning with the first menstrual cycle. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary Ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of MII oocytes, 2PN embryos, cleavage stage embryos) will be followed for six sequential months. Spontaneous pregnancies will also be recorded.

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 23, 2020
• Study Start: January 27, 2020
• Primary Completion: October 31, 2020
• Study Completion: November 21, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)