Protocol summary

Summary
For the purpose of the endometrial preparing, there are different regimes including using different products of estrogen and progesterone. Estrogen is available as a composite of valerate estradiol tablet, dermal jell, dermal and vaginal patch. Taking the side effects of oral esteroid on lipoprotein and the coagulation factors, it is useful to use estrogen jell. As a result, taking the side effects of oral esteroid into account, it is important to use products with less side effects such as jell. A study was conducted in 2016-2017 on 100 infertile women who were under treatment with the acceptance conditions (between 20-45 years old, and are candidate to frozen embryo transfer). The participants took part in the study for 6 months in Vali-asr Clinic for Infertility, and without agonist suppression they were randomly in single blind divided into two groups. In the two groups, the first day of menstrual cycle the amount of estradiol was checked. In the first group from the first day of menstrual cycle 6 mg of estradiol was daily given. After one week, ultra-sound was done, and by the start of the triple-line endometrium estradiol was checked. In the second group, from the first day of menstrual cycle 4.5 mg of estradiol jell equaling three line of the ruler and 4 mg of oral estradiol in the upper arm or thigh area was used. The two groups were compared according to estradiol serum amount, size of endometrium thickness (primary outcome) and clinical pregnancy rate (secondary outcome).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701083950N5
Registration date: 2017-03-13, 1395/12/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-13, 1395/12/23
Registrant information
Name
Mina Jafarabadei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
jafarabadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative evaluation of the effect of Estradiol jell and Valerate Estradiol tablet in preparing endometrium for frozen embryo transfer cycle without agonist suppression.
Public title
A Comparative evaluation of the effect of Estradiol jell and Valerate Estradiol tablet in preparing endometrium .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for freeze embryo transfer; age 20-45 years old. Exclusion criteria: patients candidate for fresh embryo transfer; ovarian failure; reduced response to ovarian stimulation and oocyte recipient candidates; patients with hyperstimulation ( ovaries hyperrstimulation ) that have not done embryo transfer in fresh cycles; fetus with bad quality.
Age
From 20 years old to 45 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz blvd.
City
Tehran
Postal code
14194
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1955

Health conditions studied

1

Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility, unspecified

Primary outcomes

1

Description
Endometrial thickness
Timepoint
One week after treatment
Method of measurement
Vaginal sonography

2

Description
Estradiol quantity
Timepoint
One week after treatment
Method of measurement
Lab Test

Secondary outcomes

1

Description
Clinical Pregnancy
Timepoint
Three weeks after do positive of pregnancy teset
Method of measurement
Transvaginal sonography

2

Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
B-HCG Test

Intervention groups

1

Description
Intervention group 1: the first day of menstrual cycle the amount of estradiol was checked. From the first day of menstrual cycle 6 mg of estradiol was daily given. After one week, ultra-sound was done, and by the start of the triple-line endometrium estradiol was checked. If endometrial thickness greater than 8 mm and estradiol is greater than 200 pictogram, embryo transfer is done. Intramuscular progesterone prescribe once a day (100mg) 4 days before the ET and will continue for up to 12 weeks of pregnancy.
Category
Treatment - Drugs

2

Description
Intervention group 2: from the first day of menstrual cycle 4.5 mg of estradiol jell equaling three line of the ruler and 4 mg of oral estradiol in the upper arm or thigh area was used. After one week, ultra-sound was done, and by the start of the triple-line endometrium estradiol was checked. If endometrial thickness greater than 8 mm and estradiol is greater than 200 pictogram, embryo transfer is done. Intramuscular progesterone prescribe once a day (100mg) 4 days before the ET and will continue for up to 12 weeks of pregnancy.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Infertility Clinic
Full name of responsible person
Dr. Amal Shoman
Street address
Valiasr Infertility Clinic, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Deputy of research and technolog ، Floor N.6, Central Bulding , Ghods Street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Amal Shoman
Position
Infertility Flowship
Other areas of specialty/work
Street address
First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1616
Email
amani162@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Mina Jafarabadi
Position
Associate Professor
Other areas of specialty/work
Street address
First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
minajaf@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali Asr Reproductive Health Research Center
Full name of responsible person
Fedyeh Haghollahi
Position
Researcher
Other areas of specialty/work
Street address
First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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