Effect of saline infusion ultrasonohystrography in luteal phase of previous menstrual cycle on pregnancy rate in infertile patients undergoing freeze-thawed embryo transfer cycle
Effect of saline infusion ultrasonography on pregnancy rate in infertile women undergoing freeze embryo transfer
Design
Randomized clinical trials, Phase 3, single blind, two arm parallel group.
70 patients will be included in the study.
Settings and conduct
This study is single blind and physician and outcome assessor blinded to intervention but patient aware of intervention. One nurse aware of intervention who underwent hormonal treatment with estradiol and progesterone or who underwent saline infusion in adittion to hormonal treatment on day 21 of menstrual cucle. And from day 5 of the menstrual cycle, oral contraceptive pills are started and they randomly asigned into the two groups using a random number table.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least one prior IVF failure, aged between 18-40years old, BMI between the18 and 30, no structural pathology in the uterus.
Exclusion criteria: Uterine and pelvic adhesions, A history of hypothyroidism or hyperthyroidism, prior history of three unsuccessful In vitro fertilization
Intervention groups
Intervention 1:Infusion of 20 ml saline in to the uterus during ultrasonography on day 21 of previous luteal phase of menstrual cycle.
Intervention 2: Estrogen initiation on day 3 of menstrual cycle (Estradiol Tablet, 2mg, three time a day, iran Hormone company) and contine till freeze embryo transfer day
Main outcome variables
Pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160815029374N8
Registration date:2020-05-19, 1399/02/30
Registration timing:prospective
Last update:2020-05-19, 1399/02/30
Update count:0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Marzieh Zamaniyan
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 5724
Email address
m.zamanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of saline infusion ultrasonohystrography in luteal phase of previous menstrual cycle on pregnancy rate in infertile patients undergoing freeze-thawed embryo transfer cycle
Public title
Effect of saline infusion ultrasonohystrography in luteal phase of previous menstrual cycle on pregnancy rate in infertile patients undergoing freeze-thawed embryo transfer cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients have at least one IVF loss between the ages of 18 and 40 years
BMI of patients between 18 and 30 who had no structural pathology in their uterus
Exclusion criteria:
Patients with uterine and pelvic adhesions
Hypothyroidism and hyperthyroidism have been reported
A failed IVF three-time history or 10 embryo transplants have previously been combined, and pregnancy has not occurred
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual, and randomized table methods will be divided into two groups, and only the nurse will know which patient is being treated with hormone-only estradiol plus progesterone, or saline injection on day 21 of the cycle in addition to hormone therapy. The doctor does not know which patient should be treated, but the patient knows.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the nurse knows which patient is being treated with hormone-only estradiol plus progesterone, or saline injection on day 21 of the cycle in addition to hormone therapy. The doctor does not know which patient should be treated, but the patient does not know which treatment to treat, but the patient knows.hould be treated, but the patient knows.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in the research of Imam Sari Educational and Medical Hospital - Mazandaran Universi
Street address
Amir Mazandarani Boulevard, Imam Khomeini Hospital
City
sari
Province
Mazandaran
Postal code
33131 – 48166
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.170
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 to 5 weeks after embryo transfer
Method of measurement
Test - Ultrasound
Secondary outcomes
1
Description
Miscarriage rates
Timepoint
Till twenty weeks after embryo transfer
Method of measurement
Questionnare
2
Description
Chemical pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
B-HCG Kit
Intervention groups
1
Description
Intervention group: Saline ultrasonography with 20 ml saline infusion on day 21 of late lutea phase of prior cycle
Category
Treatment - Other
2
Description
Control group: Estrogen initiation on day 3 of menstrual cycle (2 mg tab, Iran Hormone company) three time a day and continious to embryo transfer day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Sari
Full name of responsible person
Marzieh Zamanian
Street address
No. 233, ground floor section, ground floor, Imam Khomeini Hospital, Amir Mazandarani St.
City
sari
Province
Mazandaran
Postal code
5494483
Phone
+98 11 3336 5724
Fax
+98 11 3336 5724
Email
m.zamanian@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fereshteh Akrami
Street address
N0.2, Third floor, Department of Research and Technology, Teachers' Square
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Fax
+98 11 3304 4001
Email
f.akrami1919@gmail.com
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?