The effect of platelet-rich plasma injection in the ovary on the number of oocytes; Oocyte quality and antimullerian hormone in cases of poor ovarian Responses.
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General information
2020-08-30, 1399/06/09
2020-10-01, 1399/07/10
2020-0810-3001 00:00:00
2020-08-30, 1399/06/09
2020-10-01, 1399/07/10
2020-0810-3001 00:00:00
2021-08-31, 1400/06/09
2021-04-19, 1400/01/30
2021-0804-3119 00:00:00
2021-09-21, 1400/06/30
2021-06-20, 1400/03/30
2021-0906-2120 00:00:00
Protocol summary
Study aim
Evaluation of the effect of PRP on ovarian function in patients with poor ovarian response.
Design
A non-randomized clinical trial with Control group; In parallel, Phase 4 will be performed on 44 infertile women with ovarian poor response and IVF candidates.
Settings and conduct
Infertile women referring to Valiasr Infertility Clinic of Imam Khomeini Hospital Complex of Tehran University of Medical Sciences will be selected in two groups of intervention (A) and control (B) with non-random conditions. In all patients, ovarian stimulation is initiated according to the antagonist protocol and in the intervention group, immediately after the follicle reaches 17 mm, 2 cc of enriched platelet (PRP) is injected into each ovary under anesthesia, and then the steps IVF is performed. PRP is not performed in the control group and they receive routine ovarian stimulation treatments.
Participants/Inclusion and exclusion criteria
Infertile women with poor ovarian function; Antimullerian hormone between 0.5-1.1 and the presence of at least ten million sperm with 3% of normal morphology are included in the study. Underlying diseases; Chromosomal abnormalities and hemoglobin less than 11 g / dL are not included in the study.
Intervention groups
Intervention group: After stimulation of the ovary and immediately after the follicle reaches 17 mm, 2 cc of enriched platelet (PRP) is injected into each ovary under anesthesia at the same time as the puncture. In the control group, PRP is not performed and routine ovarian stimulation is performed.
Main outcome variables
The number of eggs grown and the level of the antimullerian hormone are the main outcomes and chemical pregnancy and clinical pregnancy are the secondary outcomes of the study.
General information
Reason for update
Setting primary and secondary outcomes; Set the exact study time; Set study inclusion and exclusion criteria.
Acronym
IRCT registration information
IRCT registration number:IRCT20141217020351N11
Registration date:2020-11-25, 1399/09/05
Registration timing:registered_while_recruiting
Last update:2022-01-01, 1400/10/11
Update count:2
Registration date
2020-11-25, 1399/09/05
Registrant information
Name
Ensieh Shahrogh Tehraninejad
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
etehraninejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-08-31, 1400/06/09
Actual recruitment start date
2020-10-01, 1399/07/10
Actual recruitment end date
2021-04-19, 1400/01/30
Trial completion date
2021-06-20, 1400/03/30
Scientific title
The effect of platelet-rich plasma injection in the ovary on the number of oocytes; Oocyte quality and antimullerian hormone in cases of poor ovarian Responses.
Public title
The effect of plasma injection in the ovary on the number of Follicle and oocytes, the quality of oocytes, and Anti Mullerian hormone in cases of poor ovarian function.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The second cycle of embryo transfer
Criteria for detecting poor ovarian function based on the Bologna criterion
Age less than 45 years
History of having at least three oocytes in the previous cycle
AMH hormone less than 1.1 ng / ml
BMI less than 30kg/m2
At least ten million sperm and three percent sperm with a normal morphology
Exclusion criteria:
Immunological diseases
Hematological diseases
Chromosomal or genetic disorder
Uterine disorders
Hemoglobin level less than 11 grams per deciliter
Platelets less than one hundred and fifty thousand per cubic millimeter
Systemic use of corticosteroids within two weeks before the procedure
Hypothyroidism
Respiratory tract infections
Kidney failure
Endometriosis
Sub mucusal myoma
Asherman Syndrome
Pathology of the Fallopian tubes (Hydrosalpinx)
Endocrine diseases
Endocrine diseases
Allergic reactions
The dissatisfaction of the patient to continue treatment
No contraindications for pregnancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex ,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.271
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Number of oocyte
Timepoint
Two months after the PRP
Method of measurement
Vaginal Sonography
2
Description
Antimullerian hormone
Timepoint
Two months after the PRP
Method of measurement
Blood Test
3
Description
The quality of oocyte
Timepoint
Two months after the PRP
Method of measurement
Vaginal Sonography
Secondary outcomes
1
Description
Number of obtained of embryo
Timepoint
Two months after the PRP
Method of measurement
Embryologist diagnosis
2
Description
The quality of resulted embryo
Timepoint
Two months after the PRP
Method of measurement
Embryologist diagnosis
3
Description
Chemical Pregnancy
Timepoint
Two weeks after the embryo transfer
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group:In all patients, ovarian stimulation is initiated according to the antagonist protocol and immediately after the follicle reaches 17 mm at the same time as oocyte removal; 2 cc of enriched platelet solution (PRP) is injected into each ovary under anesthesia and then IVF steps are performed.
Category
Treatment - Drugs
2
Description
Control group: In this group, PRP is not performed and only routine ovarian stimulation treatments are performed.