A comparison of the effect of intraovarian injection of autologous platelet rich plasma (PRP) versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
2021-02-08, 1399/11/20
2021-02-15, 1399/11/27
2021-02-0815 00:00:00
empty
Changing the recruitment start date
Changing the recruitment start date
empty
تغییر تاریخ شروع بیمارگیری
تغییر تاریخ شروع بیمارگیری
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abbas- Aflatoonian
Full name of responsible person - Persian: عباس افلاطونیان
Street address - English: Yazd Reproductive Sciences Institute, Bouali Ave, Safaiyeh
Street address - Persian: صفائیه خیابان بو علی پژوهشکده علوم تولید مثل
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax: +98 35 3824 7087
Email: abbas-aflatoonian@ssu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Deputy of Research and Development, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشک شهید صدوقی یزد
Full name of responsible person - English: Masoud Mirzaei
Full name of responsible person - Persian: مسعود میرزایی
Street address - English: Bahonar Square, Shahid Sadoughi University of Medical Sciences
Street address - Persian: دانشگاه علوم پزشکی شهید صدوقی، میدان باهنر
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3726 3733
Fax:
Email: dvc.research@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Deputy of Research and Development, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشک شهید صدوقی یزد Full name of responsible person - English: Abbas- AflatoonianMasoud Mirzaei Full name of responsible person - Persian: عباس افلاطونیانمسعود میرزایی Street address - English: Yazd ReproductiveBahonar Square, Shahid Sadoughi University of Medical Sciences Institute, Bouali Ave, Safaiyeh Street address - Persian: صفائیه خیابان بو علی پژوهشکدهدانشگاه علوم تولید مثلپزشکی شهید صدوقی، میدان باهنر City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 70853726 3733 Fax: +98 35 3824 7087 Email: abbas-aflatooniandvc.research@ssu.ac.ir Web page address:
Protocol summary
Study aim
The aim of this study is to compare the effect three treatment methods including gonadotropin, gonadotropin plus intraovarian injection of autologous platelet rich plasma (PRP) and PRP alone on increasing ovarian reserve.
Design
In a randomized, not-blinded, phase 2 clinical trial, without control group and using a parallel group design, 45 infertile women with diminished ovarian reserve will randomly assign into three groups of gonadotropin , PRP plus gonadotropin and PRP alone. Randomization will be performed using G power software.
Settings and conduct
This study will perform on randomized assigned 3 groups of infertile women with diminished ovarian reserve at Yazd Research and Clinical Center for infertility.
Participants/Inclusion and exclusion criteria
Include criteria:
Age 20 to48 years
Diminish ovarian reserve (AMH <0.5 ,AFC<5)
Women with a history of at least one IVF failure
Exclude criteria:
Male factor
Tubal factor
Polycystic Ovarian Syndrome
Intervention groups
The patients are Randomly assigned to one of the three groups of
gonadotropin injection, both gonadotropin plus intraovarian injection of PRP ,and intraovarian injection of PRP alone.
Main outcome variables
Increasing AMH level; Increasing AFC; Occurrence of spontaneous pregnancy
General information
Reason for update
Changing the recruitment start date
Acronym
IRCT registration information
IRCT registration number:IRCT20151013024512N7
Registration date:2021-02-11, 1399/11/23
Registration timing:prospective
Last update:2021-04-02, 1400/01/13
Update count:2
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 358247085
Email address
abbas-aflatoonian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-15, 1399/11/27
Expected recruitment end date
2021-05-04, 1400/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of intraovarian injection of autologous platelet rich plasma (PRP) versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve
Public title
Comparison of the effect of PRP versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female infertility
Diminish ovarian reserve (AMH<0.5 and AFC< 5-7)
20 to 48 years
Exclusion criteria:
Uterin anomaly
Polycystic Ovarian Syndrome
Male factor
Tubal factor
Age
From 20 years old to 48 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
45 infertile women with diminished ovarian reserve who are referred for infertility treatment will be allocated into three interventional groups via simple, individual randomization method using the table of random numbers. Randomization was previously performed for 45 cases into three groups. This is a not-blinded study. Therefore, the clinician will consecutively assign each woman with the inclusion criteria into one of the three intervention groups for receiving the specific intervention for each group
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
The Ethics Committee of Yazd Reproductive Sciences Institute, Yazd Shahid Sadoughi University of Med
Street address
Bouali Ave, Safaiyeh,Reproductive Sciences Institute
City
YAZD
Province
Yazd
Postal code
8916877391
Approval date
2020-07-19, 1399/04/29
Ethics committee reference number
IR.SSU.RSI.REC.1399.025
Health conditions studied
1
Description of health condition studied
Ovarian rejuvenation in diminished ovarian reserve patients
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure
Primary outcomes
1
Description
Increase Anti-Müllerian hormone level
Timepoint
At the beginning of the study, two and four months later
Method of measurement
Lab Test
Secondary outcomes
1
Description
Antral follicular count
Timepoint
1 to 4 months later
Method of measurement
Transvaginal sonography
2
Description
Spontaneous pregnancy
Timepoint
3 months later
Method of measurement
Lab test
Intervention groups
1
Description
Frist intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles.
Category
Treatment - Drugs
2
Description
Second intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles PLUS PRP; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP
Category
Treatment - Drugs
3
Description
Intervention group: Third intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered PRP alone; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Abbas Aflatoonian
Street address
Yazd Reproductive Sciences Institute, Bouali Ave, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas-aflatoonian@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Development, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Square, Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3726 3733
Fax
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Development, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Position
Professor, Gynecologist,Infertility Fellowship (Head of Institute)
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, Bouali Ave, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas-aflatoonian@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Position
Professor, Gynecologist,Infertility Fellowship (Head of Institute)
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, Bouali Ave, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
035382477085
Fax
+98 35 3824 7087
Email
abbas-aflatoonian@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mirzaei
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, Bouali Ave, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
maryammirzaei270@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD