Comparison of the effect local endometrial injury on implantation and pregnancy rate in follicular versus luteal phases of the menstrual cycle in patients undergoing frozen embryo transfer with a history of at least one IVF failure
The main objective of this study is to compare the efficacy of local endometrial injury (LEI) in follicular phase versus luteal phase on pregnancy rate in (frozen embryo transfer) FET cycle in women referred to Infertility Clinic of Arash Women's Hospital with a history of at least one failure in IVF.
Design
This study is designed as a clinical trial with a parallel random allocation and a 1: 1 ratio.
Settings and conduct
This clinical trial will be conducted at Arash Women's Hospital on infertile women undergoing FET. Participants will randomly be divided into two groups of 68. Local Endometrial injury (LEI) process will be performed in the follicular phase for group 1, and it will be performed in the luteal phase in gropu2. The LEI process will be performed with scratching endometrium by using an endometrial pipelle instrument. After 14 days, If the Triple line endometrium pattern is seen or endometrial thickness is above 7 mm, progesterone will be started as a Cyclogest suppository. After at least 3 to 4 days, two or three frozen embryos (two to three days old) will be transferred. serum βHCG level will be checked after 2 weeks. If the βhcg level rises more than 15 iu/L, a TVS will be performed within 5 weeks later for assessment of gestational Sac (GS). In the presence of GS, pregnant women will be followed up until 12 weeks of pregnancy.
Participants/Inclusion and exclusion criteria
Participants should: be aged under 40 years old; have normal body mass index; have a normal uterine cavity; have not used OCP or GnRH; have not to had endometrial hyperplasia or malignancy, active vaginal and cervical infections, and systemic disease.
Intervention groups
Group 1: local endometrial injury in the follicular phase
Group 2: local endometrial injury in the luteal phase
Main outcome variables
Implantation and chemical pregnancy rates
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110731007165N4
Registration date:2018-08-31, 1397/06/09
Registration timing:registered_while_recruiting
Last update:2018-08-31, 1397/06/09
Update count:0
Registration date
2018-08-31, 1397/06/09
Registrant information
Name
Ladan Kashani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 1866
Email address
kashani_ladan@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect local endometrial injury on implantation and pregnancy rate in follicular versus luteal phases of the menstrual cycle in patients undergoing frozen embryo transfer with a history of at least one IVF failure
Public title
Comparison of local endometrial injury efficacy in follicular versus luteal phases on the success rate of frozen embryo transfer cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged under 40 years old
Hysterosalpingography (HSG) or hysteroscopy showed a normal uterine cavity
Body Mass Index < 30
Have a history of one or more IVF failures
Women who were not using Oral Contraceptives (OCP) or GnRH in previous ART cycle
Have indication for LEI (Local Endometrial injury)
Patients who had given their written, informed consent for participation
Exclusion criteria:
Intrauterine abnormalities shown in sonography or imaging such as myoma, Ascherman syndrome, etc ...), endometrial hyperplasia and cancer
Active vaginal and cervical infections
Systemic disease (systemic lupus eritematoso, Diabetes, Hypertension, etc ... )
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Our considered sample size is 136 (with 68 people in each group). Block randomization method will be designed by using online randomization list provided by https://www.sealedenvelope.com
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
Qods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2911
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancy sterility, female NOS
Primary outcomes
1
Description
Chemical Pregnancy Rate
Timepoint
2 weeks after FET
Method of measurement
Pregnancy test ( BHCG )
2
Description
Implantation Rate
Timepoint
5 weeks after positive BHCG Test
Method of measurement
Trans Vaginal Sono
Secondary outcomes
1
Description
Ongoinig Pregnancy Rate
Timepoint
upto 12 weeks of gestation
Method of measurement
Diagnosis of gynecologist
Intervention groups
1
Description
in group 1: Making endometrial injury by pipelle instrument in the follicular phase ( at days 4–6 and before FET).The LEI process will be performed with scratching endometrium by using an endometrial pipelle instrument. After 14 days, If the Triple line endometrium pattern is seen or endometrial thickness is above 7 mm, progesterone will be started as a Cyclogest suppository. After at least 3 to 4 days, two or three frozen embryos (two to three days old) will be transferred. `
Category
Treatment - Other
2
Description
in group 2: Making endometrial injury by pipelle instrument in the luteal phase ( at days 21-23 and before FET). The LEI process will be performed with scratching endometrium by using an endometrial pipelle instrument. After 14 days, If the Triple line endometrium pattern is seen or endometrial thickness is above 7 mm, progesterone will be started as a Cyclogest suppository. After at least 3 to 4 days, two or three frozen embryos (two to three days old) will be transferred. `
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr.ladan Kashani
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
Kashani_ladan@tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Arash Women 's Hospital
Full name of responsible person
Dr.Zahra Parsaeian
Position
OB/GYN RESIDENT
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
zparsaiyan6@gmail.com
Web page address
http://arash.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Ladan Kashani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
Kashani_ladan@tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3195
Fax
Email
Kashani_ladan@tums.ac.ir
Web page address
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