Comparison of clinical pregnancy outcome between intrauterine injection of platelet rich plasma (PRP) and granulocyte colony stimulating factor (G-CSF) in patients with more than two failed embryo transfer cycles -clinical trial
The aim of the present study is the comparison of the clinical pregnancy outcomes of intrauterine injection of platelet-enriched plasma (PRP) and granulocyte colony-stimulating factor (G-CSF) in patients with more than two failed embryo transfer cycles.
Design
An uncontrolled, not blind, randomized clinical trial with a parallel-group design of 198 patients, enrolled between 2021 and 2022.
Settings and conduct
The present unblinded study will be performed at Mehr Medical Institute.
Two days before embryo transfer, 1.5 ml of lympho-PRP will be prepared with a platelet concentration of 4 to 5 times of basal blood, with 2000 lymphocytes / ml. Intrauterine injection of 1 ml of lympho-PRP will be performed using an IUI catheter.
Intrauterine G-CSF:
On the day of progesterone adminstration, 1 ml of G-CSF (gµ300) will be injected into the endometrial cavity using an IUI catheter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with more than two failed embryo transfer cycles with top and good embryos; Age <41 years old.
Exclusion criteria: contraindications for G-CSF use; contraindications for PRP use; Poor ovarian response according to Bologna criteria; PGS / PGD cycles; Genetic disorders; Ovum donor and surrogacy; Severe endometriosis; Severe male factor; Cycles without transferable embryos; G-CSF allergy.
Intervention groups
Intrauterine PRP:
Two days before embryo transfer, intrauterine injection of 1 ml of lympho-PRP will be performed using an IUI catheter.
Intrauterine G-CSF:
On the day of progesterone adminstration, 1 ml of G-CSF (gµ300) will be injected into the endometrial cavity using an IUI catheter.
Main outcome variables
Clinical pregnancy; Ongoing pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180528039878N3
Registration date:2021-05-08, 1400/02/18
Registration timing:prospective
Last update:2021-05-08, 1400/02/18
Update count:0
Registration date
2021-05-08, 1400/02/18
Registrant information
Name
Marzieh Mehrafza
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 4270
Email address
dr.Mehrafza@mehrinstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical pregnancy outcome between intrauterine injection of platelet rich plasma (PRP) and granulocyte colony stimulating factor (G-CSF) in patients with more than two failed embryo transfer cycles -clinical trial
Public title
Comparison of intrauterine PRP versus G-CSF in RIF patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than two failed cycles of top and good embryo transfer
Age <41 years
Exclusion criteria:
G-CSF Contraindications,
PRP Contraindications,
Poor ovarian response according to Bologna criteria,
PGS / PGD cycles,
Genetic disorders,
Ovum donor or surrogacy,
Severe endometriosis,
Severe male factor,
No embryo transfer cycles
G-CSF allergy
Age
To 41 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
198
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using seal enveloped software. The list of blocks will be written and numbers will be assigned to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)), then random numbers between one and six ( For example, 1 4 5, etc.) will be select and finally the treatment allocation list based on previous random numbers (AABB, BBAA, BABA, etc.) will be specified.
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
Guilan University of Medical Sciences
Street address
Shahid Siadati Ave – Namjoo St – Rasht- IRAN
City
Rasht
Province
Guilan
Postal code
66949-41446
Approval date
2021-04-07, 1400/01/18
Ethics committee reference number
IR.GUMS.REC.1400.017
Health conditions studied
1
Description of health condition studied
Repeated implantation failure
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
Six weeks after embryo transfer
Method of measurement
Ultrasonography
2
Description
Ongoing pregnancy
Timepoint
Twelve weeks after embryo transfer
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Biochemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
beta-hCG measurement
Intervention groups
1
Description
Intervention group: Intrauterine injection of PRP: Endometrial preparation will be started using estradiol (4 mg daily) and ASA. From day 6, 6 mg of estradiol will be given daily. Depending on the age of the embryo, progesterone (400 mg suppository, 100 mg intramuscular) will be given for 3 to 5 days.Two days before embryo transfer, peripheral venous blood (8.5 ml) will be drawn into a 10 ml syringe containing 1.5 ml of anticoagulant solution. According to ROOYAGEN's recommended instructions, 1.5 ml of lympho-PRP with a platelet concentration of 4 to 5 times the basal blood with 2000 lymphocytes / ml will be prepared. Intrauterine injection of 1 ml of lympho-PRP will be performed using an IUI catheter.
Category
Treatment - Other
2
Description
Intervention group: Intrauterine G-CSF: Endometrial preparation will be started using estradiol (4 mg daily) and ASA. From day 6, 6 mg of estradiol will be given daily. Depending on the age of the embryo, progesterone (400 mg suppository, 100 mg intramuscular) will be given for 3 to 5 days. On the day of progesterone initiation, 1 ml G-CSF (gµ300) will be injected into the endometrial cavity using an IUI catheter.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3376 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3376 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehr Medical Institute
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
Fertility Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3376 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
Subspecialist
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Medical Institue, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3376 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org
Person responsible for updating data
Contact
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
Subspecialist
Latest degree
Subspecialist
Other areas of specialty/work
Reproductive Biology
Street address
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 0076 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available