Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency
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|ClinicalTrials.gov Identifier: NCT04237909|
Recruitment Status : Completed
First Posted : January 23, 2020
Last Update Posted : November 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Premature Ovarian Failure Diminished Ovarian Reserve||Biological: PRP injection into at least one ovary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 27, 2020|
|Actual Primary Completion Date :||October 31, 2020|
|Actual Study Completion Date :||November 21, 2020|
Experimental: Ovarian Reserve
Patients with diminished ovarian reserve or premature ovarian insufficiency
Biological: PRP injection into at least one ovary
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 parameters [ Time Frame: 6 months ]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.
- Ovarian response to stimulation [ Time Frame: 12 months ]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.
- IVF outcomes [ Time Frame: 15 months ]Number of participants with ovarian PRP as assessed by number of clinical pregnancies, change in the percentage of clinical pregnancy rates with IVF treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237909
|Istanbul, Turkey, 34752|
|Study Director:||Yigit Cakiroglu, Assoc.Prof.||Acibadem University|