Evaluation of serum progesterone level on the day of embryo transfer in frozen cycle at cleavage stage on pregnancy outcomes in two routes of luteal phase support in infertile women refereed to Infertility center affiliated to Hormozgan University of Medical Sciences : A randomized clinical trial study
Evaluation of serum progesterone level on the day of embryo transfer in frozen cycle at cleavage stage on pregnancy outcomes in two routes of luteal phase support
Design
classification into two groups (IM group, Crinone group) 3 days before FET, freezed embryo transfer, evaluation of pregnancy outcomes
Settings and conduct
All infertile participants referred to the infertility center after obtaining informed consent involve the study and receive hormone therapy for preparing the endometrium for embryo transfer and subsequent rerceive luteal phase support. All patients are randomly divided into two groups before starting treatment:
Group 1: Administration of 100 mg of progesterone as IM (two ampoules of 50 mg) from 3 days before embryo transfer until pregnancy test
Group 2: Administration of 8% crinone gel (90 mg once daily) from 3 days before embryo transfer until pregnancy test
In all patients, 2-3 good quality embryos are transferred 96 hours after the start of progesterone administration. Serum progesterone levels are measured 1 hour before embryo transfer and the pregnancy outcomes in each patient are assessed and the relationship between serum progesterone levels and these outcomes is assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Artificial endometrial preparing
18-37 years.
ICSI/IVF cycles
Having 2-3 high quality embryos
Patients with normal uterine cavity
Exclusion criteria:
Patients with uterine problems
Patients with a history of recurrent miscarriage
RIF patients
Age over 37 years
Patients with grade 3 or 4 endometriosis
Poor Embryo quality
Ectopic pregnancy
Patients with endometrial thickness less than 7 mm after hormone therapy
Intervention groups
Group1: women receiving progesterone IM
Group2: women receiving vaginal progesterone ( crinone gel 8%)
Evaluation of serum progesterone level on the day of embryo transfer in frozen cycle at cleavage stage on pregnancy outcomes in two routes of luteal phase support in infertile women refereed to Infertility center affiliated to Hormozgan University of Medical Sciences : A randomized clinical trial study
Public title
Evaluation of serum progesterone level on the day of embryo transfer in frozen cycle at cleavage stage on pregnancy outcomes in two routes of luteal phase support in infertile women refereed to Infertility center affiliated to Hormozgan University of Medical Sciences : A randomized clinical trial study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
ICSI/FET cycles
Having 2-3 high quality embryo
Patients with normal uterine cavity
Infertile women between 18-37 years
Artificial Endometrial preparing
Exclusion criteria:
RIF patients
Aged over 37 years
Patients with a history of recurrent miscarriage, implantation problem
Patients with uterine abnormality like Fibroma, uterine anatomical problems, Polyp, intramural Myoma greater than 4 cm, salpangitis
Patients with grade 3 or 4 endometriosis
Body mass index higher than 30 kg / m2
Patients using two types of progesterone to support the luteal phase
Patients with blastocyst transfer (fifth day embryo)
Ectopic pregnancy
Patients with endometrial thickness less than 7 mm after hormone therapy
Poor quality embryo
Age
From 18 years old to 37 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Eligible patients (including 100 patients) are randomly assigned by a statistical expert using a simple randomization method. In this method, the Random function between the Excell program is used to generate a random number between 1 and 2. This is repeated 100 times and thus a random sequence is obtained.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Imam Hossein Boulevard
City
Bandar abbas
Province
Hormozgan
Postal code
7919693116
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.HUMS.REC.1400.192
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Biochemical pregnancy
Timepoint
14 days after FET
Method of measurement
beta serum level evaluation
2
Description
Clinical pregnancy
Timepoint
6 week after FET
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receiving progesterone as IM
Category
Treatment - Drugs
2
Description
Intervention group 2: receiving vaginal progesterone( crinone gel 8%)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center affiliated to Hormozgan University of Medical Sciences
Full name of responsible person
Dr.Maryam Azizi kutenaee
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr.taymoor Aghamolaee
Street address
Imam Hossein Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Maryam Azizi kutenaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333
Email
maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Maryam Azizi Kutenaee
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Ensieh Salehi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Parastar Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
salehiensieh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
The data will be presented in the article after analysis
When the data will become available and for how long
2022
To whom data/document is available
Academic researchers and Gynecologist
Under which criteria data/document could be used
Clinical application in patients undergoing ICSI/FET
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document