Determining the effect of Plasma richplatelet on IVF cycle outcome in poor responder patients
Design
This study is a before-after study that will be conducted in Shahid Beheshti Hospital, Kashan. This study will be conducted on 15 poor responder patients of Poseidon group 3 and 1
Settings and conduct
It includes people who refer to the infertility center of Shahid Beheshti Hospital in Kashan in 2022 and 15 people will be selected based on the entry and exit criteria.Before entering the IVF cycle, patients perform FSH and AMH hormone tests. If a follicle with a size of 12 to 14 micrometers is observed, the patient is prescribed Sterotide. When 2 or more than 2 follicles with a size of 17 or more than 17 mm are seen in the ultrasound, 36 hours after the final stimulation of the follicle, ovarian puncture is performed, and after the puncture, 5.2 cc of PRP is injected into each The ovary is injected.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are age less than 35 years, BMI less than 30 and AMH<1.2 ng/ml AFC<5 or under 35 years and a history of poor response during IVF cycle with AMH>1.2 ng/ml AFC>5 Exclusion conditions are hematological disorders, immunological disorders,
Intervention groups
Fertility in women who belong to Poseidon 1-3 which is measuring ovarian stimulating hormone and anti-Müllerian hormoneendometrial thickness, embryo quality oocyte number and oocyte size before and after administration of PRP.
Main outcome variables
Investigating the effect of PRP on the outcome of the IVF cycle on the number of follicles larger than 17 mm
on the number of antral follicles and the number of M2 oocytes and the percentage of fertilization and the number of embryos
Weber embryo quality Weber endometrial thickness
General information
Reason for update
Acronym
PRP in infertility
IRCT registration information
IRCT registration number:IRCT20220809055651N1
Registration date:2022-10-30, 1401/08/08
Registration timing:registered_while_recruiting
Last update:2022-10-30, 1401/08/08
Update count:0
Registration date
2022-10-30, 1401/08/08
Registrant information
Name
Zahra Usefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 8827
Email address
usefi-z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of PRP on the outcome of IVF cycle in poorly responding patients
Public title
PRP in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
This study will be conducted on 15 poor responder patients of group 3 and 1 poseidon. Inclusion criteria: age less than 35 years, BMI less than 30 and AMH<1.2 ng/ml AFC<5 (group 3 Poseidon) or women under 35 years and a history of poor response during IVF cycle with AMH >1.2 ng/ml AFC >5 (Group 1 of Poseidon).
Exclusion criteria:
Hematological disorders (leukemia, thrombocytopenia), immunological disorders (antiphospholipid syndrome, thrombophilia), hormonal disorders (diabetes, thyroid, hyperprolactinemia), chromosomal and genetic abnormalities (hereditary or congenital) and kidney failure.
Age
To 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Hematological disorders (leukemia, thrombocytopenia), immunological disorders (antiphospholipid syndrome, thrombophilia), hormonal disorders (diabetes, thyroid, hyperprolactinemia), chromosomal and genetic abnormalities (hereditary or congenital) and kidney failure.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Evaluation of the effect of PRP on the outcome of IVF cycle in poorly responding patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Before entering the cycle on the fifth day of the eighth and three months later
Method of measurement
Ultrasound
2
Description
Oocyte count
Timepoint
Before entering the cycle on the fifth day of the eighth and three months later
Method of measurement
Ultrasound (sonography)
Secondary outcomes
1
Description
ANTI MOULLERIAN HORMON
Timepoint
Before entering the cycle on the fifth day of the eighth and three months later
Method of measurement
Measurement by blood test analysis after eight hours of fasting and without intimacy and stress the night before
2
Description
Follicle-stimulating Hormone
Timepoint
Before entering the cycle on the fifth day of the eighth and three months later
Method of measurement
Measurement by blood test analysis after eight hours of fasting and without intimacy and stress the night before
Intervention groups
1
Description
The present study is a before and after clinical trial study that will be conducted in Shahid Beheshti Hospital, Kashan. This study will be conducted on 15 poor responder patients of group 3 and 1 poseidon. The IVF cycle begins with the administration of HMG at a dose of 300 IU/d, and on the fifth day, ultrasound stimulation is performed again. If a follicle with a size of 12 to 14 micrometers is observed, the patient is prescribed Sterotide (MG0.25). When 2 or more than 2 follicles with a size of 17 or more than 17 mm are seen in ultrasound,The final follicle stimulation is done by prescribing HCG 10000 + ptyl 0.2mg Decape for the patient. HMG Vestrotide brand is one of the drugs available in the market and PRP is Avigen brand. 36 hours after the final follicle stimulation, the ovary is punctured and after the puncture at the rate of 2.5 CC PRP is injected into each ovary. 3 months after PRP administration, FSH and AMH levels are measured in the same people, and IVF cycles are performed again with the same method as before, and the number of follicles with a size of 17 micrometers or more, the number of M2 oocytes, the percentage of fertilization, the number of embryos and the quality The embryo and the thickness of the endometrium are examined. Finally, all these criteria that were mentioned are compared with the time before PRP administration.