Investigating the effect of growth hormone intrauterine injection along oral hormone replacement on refractory thin endometrium in frozen embryo transfer cycle
Design
Before-after clinical trial on 25 patients with refractory thin endometrium
Settings and conduct
It is a before-after intervention study that will be carry out in Al-Zahra univercity hospital. every other day injection of 5 units intrauterine growth hormone, under the guide of abdominal ultrasound with a special catheter of IUI, until the thickness of the endometrium exceeds 7 mm, maximum 5 times.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Women aged 19-45 years with thin endometrium, less than 7 mm, and history of cancellation of fetal transfer cycle during hormone transfer therapy cycle
2. Normal hysteroscopy during the last 6 months
3. Informed consent
Exclusion criteria:
1. Diabetics
2. History of any cancer
3. Cardiovascular Disease
4. Prohibition of pregnancy
5. Adenomyosis and uterine fibroids
6. Women who are contraindicated in using estrogen for any reason, such as a history of thrombosis, liver disease, dyslipidemia
Intervention groups
25 infertile women aged 19-45 years with a history of cancellation of the embryo transfer cycle due to thin endometrium during the previous frozen embryo transfer hormone therapy cycle are included in this study
Effect of growth hormone intrauterine injection along oral hormone replacement on refractory thin endometrium in frozen embryo transfer cycles
Public title
Effect of growth hormone in the treatment of infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
25 infertile women aged 19-45 years with a history of endometrial thickness less than 7 mm on the last day of endometrial preparation with estrogen in the previous cycle of embryo transfer.
Exclusion criteria:
Age over 45 years, Diabetic patients, History of cancer, Cardiovascular disease, Any disease that threatens the mother's life and prohibits pregnancy and fetal transfer, Uterus with adenomyosis and uterine fibroids, History of thrombosis, liver disease, Dyslipidemia
Age
From 19 years old to 45 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
25
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 Tabriz Medicine University
Street address
Baghshomal Ave, Alzahra Hospital,Tabriz city, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.TBZMED.REC.1399.1039
Health conditions studied
1
Description of health condition studied
Women infertility
ICD-10 code
N97
ICD-10 code description
Women infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
Check of serum BHCG
2
Description
Clinical pregnancy
Timepoint
4weeks after embryo transfer
Method of measurement
Seeing intra uterine gestational sac in vaginal sonography
3
Description
Ongoing pregnancy
Timepoint
10 weeks after embryo transfer
Method of measurement
Sonography and see the heart beat of embryo
4
Description
Increase in endometrial thickness after intrauterine infusion of growth hormone
Timepoint
Measurement endometrial thickness at the beginning and at the end day of intrauterine growth hormone injection
Method of measurement
Trans sagittal vaginal sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this prospective after-before interventional study, 25 patients aged 19-45 years with a history of endometrial thickness less than 7 mm in the estrogen therapy cycle of frozen embryo transfer are studied to evaluate the effect of intrauterine growth hormone injection on increasing endometrial thickness. These people underwent vaginal ultrasound on the second day of the menstrual cycle and if no dominant follicle is seen, the necessary treatment for endometrial preparation with oral estradiol valerate tablets, 2 mg tablets of Abu Reihan Company, Tehran, Iran, at a dose of 2 mg three times a day, It starts for 7 days, then the second ultrasound is performed and the thickness of the endometrium is measured in the longest part of the longitudinal section. If the thickness of the endometrium is less than 7 mm, the dose of the drug is 8 mg, 2 mg 4 times a day, for four days. A few days after taking a high dose of the drug, the thickness of the endometrium in the longitudinal section of the uterus is measured twice. On day 12-14 of the cycle, if the thickness of the endometrium is less than 7 mm, a slow intrauterine injection every other day, 5 units of growth hormone ,Sinatropin drug form from Sinagen Company, Basu Rat 5 ml in 1.5 cc containing 15 units of growth hormone and diluted with 0.3 ml of normal saline 0.9% percent and 0.6 cc of this solution contains 5 units of growth hormone, under the guide of abdominal ultrasound with a special catheter, Labutek-Germany, is performed until the endometrial thickness reaches or equal to 7 mm, maximum 4-5 times. If the thickness does not increase, the cycle is canceled and if the thickness increases to 7 mm and above, two days later serum estradiol level is measured. Progesterone ampoules are injected 100 mg daily for 3-5 days depending on the type of embryo transferred. Progesterone ampoules are continued for up to 12 weeks in case of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Alieh Gasemzade
Street address
Baghshomal Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
gasemzadeha@tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alieh Ghasemzadeh
Street address
Baghshomal Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 9161
Email
alghasemzadeh@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Soghra Hosseini Aghdam
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Baghshomal Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6579351386
Phone
+98 41 3553 9161
Email
dr.s.aghdam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alieh Ghasemzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Baghshomal Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6579351386
Phone
+98 41 3553 9161
Email
alghasemzadeh@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Baradaran-Binazir
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Daneshgah Aven
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4672
Email
maryam_baradaran@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no more information
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
article
When the data will become available and for how long
2021
To whom data/document is available
all ones
Under which criteria data/document could be used
citation- practice
From where data/document is obtainable
web site of journal
What processes are involved for a request to access data/document