Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone administration method and natural modified method in frozen embryo transfer cycle.
Design
The current study is a clinical and prospective study. Patients are randomly assigned to two endometrial preparation groups. Basic ultrasound is performed for 100 patients on day 2 of the cycle and they are planned to be placed in each of the endometrial preparation protocols.
Settings and conduct
This study is conducted in Imam Khomeini Hospital in Sari
Patients in the modified normal cycle group undergo an ultrasound scan on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by Ovitrelle injection, and progesterone begins three days later of Ovitrelle injection . will be For patients in the hormone administration cycle group treated with estradiol valerate, ultrasound is performed starting from the 2nd day of menstruation and approximately 10 days after the start of estradiol treatment, when the thickness of the endometrium reaches 8 mm, progesterone will start.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Age 20-40 years with monthly menstrual cycles; Normal BMI (18-30 kg/m2)
; At the time of embryo transfer, at least one or two high quality embryos;
Patients with first or second transfusion
Exit criteria:
A history of frequent miscarriages;
Observation of uterine and ovarian abnormalities
Intervention groups
Two groups of frozen embryo transfer with endometrium preparation protocol with hormone administration method and natural modified method
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240302061147N1
Registration date:2024-05-27, 1403/03/07
Registration timing:registered_while_recruiting
Last update:2024-05-27, 1403/03/07
Update count:3
Registration date
2024-05-27, 1403/03/07
Registrant information
Name
Farnaz Safarloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 508 3244
Email address
safarloo203@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
Public title
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-40 years with monthly menstrual cycles of 21 to 35 days
Normal BMI (18-30 kg/m2)
At the time of embryo transfer, there should be at least one or two embryos with A-B quality
Patients with first or second transfer
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Infertile patients who refer to Imam Hospital in Sari city, after obtaining their consent, are randomly assigned in a one-to-one ratio and enter one of the two endometrial preparation groups. Blocking is done in each group based on age (less than 35 years old and 35 to 40 years old).
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 Mazandaran University of Medical Sciences
Street address
Mazandaran Province, Sari City, Amir Mazandarani Street, Imam Khomeini Hospital, Nazaei Department
City
sari
Province
Mazandaran
Postal code
4816633131
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
ir.mazums.imamhospital.rec.1402.125
Health conditions studied
1
Description of health condition studied
Frozen embryo transfer in modified natural cycle
ICD-10 code
N97.4
ICD-10 code description
Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle
Primary outcomes
1
Description
Clinical pregnancy so that the heartbeat of the fetus can be seen in ultrasound
Timepoint
5 weeks after embryo transfer
Method of measurement
By transvaginal ultrasound
Secondary outcomes
1
Description
The rate of chemical pregnancy in which only the pregnancy test is positive
Timepoint
2 to 3 weeks after embryo transfer
Method of measurement
Laboratory test and transvaginal ultrasound
2
Description
Miscarriage rate of lack of fetal development after observing gestational sac in ultrasound
Timepoint
5 to 6 weeks after embryo transfer
Method of measurement
Trans vaginal ultrasound
3
Description
Endometrial thickness on the day of embryo transfer
Timepoint
Embryo transfer day
Method of measurement
Trans vaginal ultrasound
Intervention groups
1
Description
Intervention group: Patients in the modified normal cycle (mNC-FET) group underwent transvaginal ultrasound on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle and thus the ovulation induction time. If the ovulation induction time is not determined on the 12th day, the transvaginal ultrasound is repeated 2 days later. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by injecting 0.25 micrograms of r-hCG (6500 IU Ovitrelle). Embryo transfer will be done 5-6 days after ovulation induction, and they will receive 800 mg of micronized progesterone daily for four to five days until the time of embryo transfer, and based on the condition of the frozen embryo, 24-48 hours before the time set for Transfer will melt.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Dr. Sepideh Peivandi
Street address
Amir Mazandarani St
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
emamsarih@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Farhad Gholami
Street address
Imam Khomeini Square, Joibar Street, the beginning of Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
ravabetomoomi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
10
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
Mazandaran University of Medical Sciences
Full name of responsible person
Farnaz Safarlou
Position
Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Center of Imam Khomeini Hospital, Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Safarloo203@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farnaz Safarlou
Position
Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Center of Imam Khomeini Hospital, Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Safarloo203@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farnaz Safarloo
Position
Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility Center, Imam Khomeini Hospital, Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Safarloo203@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The design protocol, demographic information of the patients, and statistical results will be published as an article after the end of the study
When the data will become available and for how long
After publication in one of the authoritative publications
To whom data/document is available
Academic centers and infertility researchers
Under which criteria data/document could be used
Research exploitation
From where data/document is obtainable
Email of researchers and Mazandaran University of Medical Sciences
What processes are involved for a request to access data/document