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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
Sponsor:
Information provided by (Responsible Party):
Bulent Tiras, Acibadem University

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.

Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Diminished Ovarian Reserve Biological: PRP injection into at least one ovary Not Applicable

Detailed Description:
Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of at least one prior failed IVF cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 35 cm 17 G needle under transvaginal ultrasound guidance. On the 2-4th days of the first six menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing- aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   20 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Turkey
Acıbadem University
Istanbul, Turkey, 34752
Sponsors and Collaborators
Acibadem University
Investigators
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Study Director: Yigit Cakiroglu, Assoc.Prof. Acibadem University
Publications of Results:
Other Publications:
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Responsible Party: Bulent Tiras, Prof., Acibadem University
ClinicalTrials.gov Identifier: NCT04237909    
Other Study ID Numbers: ATADEK 2019/8-18
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases