Comparison of the consequences of freezing embryo transfer in infertile women with tamoxifen and recombinant gonadotropin group with GNRH agonist group and estradiol valerate
Comparison of the consequences of freezing embryo transfer (chemical and clinical pregnancy) in infertile women in the induction group with tamoxifen and recombinant gonadotropin with the GNRH agonist group and estradiol valerate
Design
controlled clinical trial, with parallel groups, one-way blind, randomized, on 192 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
Milad Hospital
Participants/Inclusion and exclusion criteria
Infertile women (18-42 years old) who go to Milad Infertility Center for freezing embryo transfer have a history of two or more failed embryo transfer. Couples who are not severely infertile or TESE candidate (Testicular Sperm Extrection) may not have severe grade 3 and 4 endometriosis, may not have fibroids> 4 cm, may not be candidates for fresh embryo transfer, and may not have primary and secondary amenorrhea.
Intervention groups
Tamoxifen 20 mg twice daily from the third day of the cycle for five days, and HMG is given at a dose of 150 mg daily on days 6 and 8.
Main outcome variables
The frequency of chemical and clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041503N3
Registration date:2020-06-25, 1399/04/05
Registration timing:registered_while_recruiting
Last update:2020-06-25, 1399/04/05
Update count:0
Registration date
2020-06-25, 1399/04/05
Registrant information
Name
Malihe Mahmoudinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9878
Email address
mahmoudiniam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
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
Comparison of the consequences of freezing embryo transfer in infertile women with tamoxifen and recombinant gonadotropin group with GNRH agonist group and estradiol valerate
Public title
Comparison of embryo transfer in two different protocol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women (18-42 years old) who go to Milad Infertility Center for transfer freezing embryo with a history of two or more failed embryo transfer.
Couples who are not severely infertile or TESE candidate (Testicular Sperm Extrection) .
may not have severe grade 3 and 4 endometriosis.
may not have fibroids> 4 cm.
may not be candidates for fresh embryo transfer.
and may not have primary and secondary amenorrhea.
Exclusion criteria:
Failure to remove the fetus from the freezer, ,
necrotic embryo
patient dissatisfaction during treatment to continue the study
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
-Simple randomization.
-In this randomized clinical trial involving 192 women (18-42 years), two groups were randomly assigned.
-Method used to generate random allocation sequence by mentioning the name of the software or site used: Computer random assignment list produced with PASS software.
-We have no way to hide Allocation Concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups.
It is not possible for patients to be blind because the type of medication prescribed to patients (injectable and oral) varies in two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad university of medical sciences Ethics committee
Street address
Vice chancellor of Research, Mashhad university of Medical Sciences, Mashhad University of Medical Sciences ,University Avenue.Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.003
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
chemical pregnancy rate
Timepoint
2 week after embryo transfer
Method of measurement
BHCG
2
Description
The rate of clinical pregnancy
Timepoint
6 weeks after embryo transfer
Method of measurement
Sonography
Secondary outcomes
1
Description
ongoing pregnancy
Timepoint
Continue pregnancy for up to 12 weeks
Method of measurement
Transvaginal ultrasound
Intervention groups
1
Description
The intervention group included 96 patients who were given 20 mg of tamoxifen twice daily for the third day of the cycle for five days, and HMG was given at 150 mg daily on days 6 and 8. Subsequent patient evaluation is performed on days 9 to 10 of the cycle with transvaginal ultrasound to measure the diameter of the follicle and the thickness of the endometrium. And if the thickness of the endometrium is 8 mm and the diameter of the dominant follicle is 18 mm, HCG10000 IU is injected to induce ovulation. 36 hours after HCG injection, the progesterone utrogestan (Besrogestan, Besins, Brussels, Belgium) 200 mg vaginal 200 mg three times daily or 100 mg endometriosis three times a day. Progesterone continues until the pregnancy test results. Endometrial thickness per day HCG Is checked.
Category
Treatment - Drugs
2
Description
Control group: In the control group, the OCP receives for 21 days, and on the 21st day of the cycle, one-third of the 3.75 decapeptil is prescribed. On the second day of the next cycle, estradiol is started at a dose of 4 mg and after three days it is converted to 6 mg. On the ninth day, ultrasound is performed in terms of endometrial thickness and increases to a maximum of 8 mg per day as needed. 100 ml endometrium is started three times a day. Progesterone is given for 5 days for blastocyst.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility center
Full name of responsible person
Malihe Mahmoudinia
Street address
Milad Infertility center, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
2
Recruitment center
Name of recruitment center
Milad infertility center
Full name of responsible person
Nayereh Khadem
Street address
Milad infertility center, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3583 1204
Email
mahmoudiniam941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen, Tafaghodi
Street address
Vice Chancellor of Research, Mashhad university of Medical sciences, university Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maliheh Mahmoudinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Fertility clinic, East Razi Streat, Dah e Day Square.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3853 4021
Email
MahmoudiniamM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nayyereh Khadem
Position
professor of gynecology group
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Ebne Sina Streat
City
Mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3801 2607
Email
khademn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Mahmoudinia
Position
Mashhad University of Medical
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Milad Fertility clinic , East Razi Streat , Dah e Day square
City
Mashhad
Province
Razavi Khorasan
Postal code
9178631973
Phone
+98 51 3853 4021
Email
MahmoudiniaM@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available