Correlation between beta Human chorionic gonadotropin (β-Hcg) on day ۱۴ after embryo transfer and pregnancy outcome in IVF cycles
This study was designed to evaluate the relationship between human placental beta gonadotropin on day 14 after embryo transfer and pregnancy outcome in IVF cycles.
Design
In this prospective cross-sectional study, 177 infertile women referred to Yas Hospital for embryo transfer. All participants entered the study after performing the necessary interventions and in case of the results of the beta hatch test CG above 25, and all the information of the questionnaire was completed during the performed ultrasounds.
Settings and conduct
In this study, 177 infertile women who are candidates for carpet or frozen transfer in Yas Hospital have been selected by convenience sampling. After the necessary interventions, participants are examined for clinical pregnancy certainty and all information is recorded in a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: body mass index below 30; Age 20 to 42 years; Above 25 Beta Hatch CG number on day 14
Inclusion criteria: the presence of any uterine anomaly; Existence of chronic diseases (such as cardiovascular); Use of group D and X drugs during pregnancy
Intervention groups
All participants received 6 mg of estradiol daily on the second or third day of their menstrual cycle. Once the endometrium has reached a thickness of 8 mm, a 50 mg progesterone ampoule is given twice daily for three days until embryo transfer.
Main outcome variables
Estradiol levels; Endometrial thickness; Biochemical pregnancy; Number of embryos transferred; Number of pregnancy sacs; Implantation rate; Clinical pregnancy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120104008611N13
Registration date:2022-04-05, 1401/01/16
Registration timing:registered_while_recruiting
Last update:2022-04-05, 1401/01/16
Update count:0
Registration date
2022-04-05, 1401/01/16
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-16, 1400/12/25
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Correlation between beta Human chorionic gonadotropin (β-Hcg) on day ۱۴ after embryo transfer and pregnancy outcome in IVF cycles
Public title
Relationship between beta gonadotropin and pregnancy outcome in the in vitro fertilization cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index below 30
Age between 20 to 42 years
Have at least 3 grade A or B embryos
All ladies with fresh or frozen transitions
Above 25 Beta Hatch CG number on day 14
Exclusion criteria:
Uterine anomaly
Submucosal myoma
Endometrial polyps
Existence of chronic diseases (such as cardiovascular)
Use of group D and X drugs during pregnancy
Age
From 20 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
177
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medical Sciences and Health Services, University of Tehran
Street address
Tehran University of Medical Sciences, Central Building, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.853
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Assess endometrial thickness
Timepoint
The second or third day of the menstrual cycle
Method of measurement
Using an ultrasound machine
2
Description
The estradiol level
Timepoint
At the beginning of the study until the endometrial thickness reaches 8 mm
Method of measurement
Blood sample
Secondary outcomes
1
Description
Biochemical pregnancy
Timepoint
Once, 14 days after fetus transfer
Method of measurement
Blood sampling
2
Description
Clinical pregnancy
Timepoint
Once, 6 to 8 weeks after embryo transfer
Method of measurement
Observation of pregnancy sac and heart rate on ultrasound
Intervention groups
1
Description
Intervention group: Receiving estradiol 6 mg daily on the second or third day of the menstrual cycle, then after reaching a thickness of 8 mm endometrium, receiving 50 mg progesterone ampoule twice a day for three days until embryo transfer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Hamideh Pakniat
Street address
Yas hospital, Next to the sarv street, North Nejatollahi street, karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
hpakniat@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Sahraiyan
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3689
Email
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
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
hpakniat@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Kosar Hospital, Taleghani St., Qazvin
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
hpakniat@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani St., Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Email
hpakniat@qums.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The collected information is in the form of a questionnaire and is statistically analyzed.
When the data will become available and for how long
The start of the access period is one year after the results are published
To whom data/document is available
For obstetricians and researchers working in academic institutions
Under which criteria data/document could be used
Evaluate the path and process of study and analyze it
From where data/document is obtainable
For information, refer to Dr. Hamideh Pakniat. The communication channels are as follows: By sending an email to the address: hpakniat@qums.ac.ir or refer and contact Kosar Hospital at the address: Taleghani St, Qazvin. Phone: 028-33236374 Postal address: 34156-13176
What processes are involved for a request to access data/document
After sending the e-mail, the requested information will be reviewed by the facilitator and the person responsible for the scientific response of the study. At your discretion, the requested information will be sent within 10 days after receiving the email.