Premature Ovarian Failure Clinical Trial
Official title:
Effects of Intraovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve and IVF Outcome Parameters in Women With Premature Ovarian Insufficiency and Poor Ovarian Response
Verified date | November 2020 |
Source | Acibadem University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | November 21, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 48 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Acibadem University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Acibadem University |
Turkey,
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. — View Citation
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 lo — View Citation
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. — View Citation
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 Chro — View Citation
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: 10.1080/095 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | IVF outcomes | Number of participants with ovarian PRP as assessed by number of clinical pregnancies, change in the percentage of clinical pregnancy rates with IVF treatment. | 15 months | |
Primary | 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 | Ovarian response to stimulation | Number of participants with intraovarian injection of autologous PRP as assessed by number antral follicle counts on ultrasound, eggs, and embryos in the laboratory, change from baseline in number of developing follicles, and percentage of obtained eggs and fertilized embryos. | 12 months |
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