The purpose of this study was to determine the effect of combination therapy of Methotrexate with Vitamin A , in patients with low risk GTN (Gestational Trophoblastic Neoplasia. Intervention group, 19 patients with low-risk gestational trophoblastic neoplasia pulse weekly intramuscular methotrexate weekly associated with intravenous dose of 200,000 IU of vitamin A for 8 were. The control group received weekly intramuscular methotrexate weekly pulses. Serum levels of the hormone human chorionic gonadotropin beta (less than 5 international units per liter) in both groups will be reviewed on a weekly basis. Chemotherapy treatment and side effects of the two groups are compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120615676N1
Registration date:2014-12-19, 1393/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Sedigheh Ghasemian Dizaj Mehr
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
ghasemians901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-10-09, 1392/07/17
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin A on the Gestational Trophoblastic Neoplasia low risk pregnancy
Public title
Effect of combination therapy of Methotrexate with Vitamin A , in patients with low risk GTN (Gestational Trophoblastic Neoplasia)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: low risk Gestational Trophoblastic Neoplasia.
Exclusion criteria: pregnancy, side effects including methotrexate and vitamin A, medical diseases (diseases of the cerebral, eye, cutaneous, liver).
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
Approval date
2013-10-09, 1392/07/17
Ethics committee reference number
920326
Health conditions studied
1
Description of health condition studied
Gestational Trophoblastic Neoplasia
ICD-10 code
D09.7
ICD-10 code description
Carcinoma in situ of other specified sites
Primary outcomes
1
Description
Beta HCG
Timepoint
Weekly
Method of measurement
mIU/ml
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: pulse weekly intramuscular methotrexate weekly associated with intramuscular dose of 200,000 IU of vitamin A for 8
Category
Treatment - Drugs
2
Description
pulse weekly intramuscular methotrexate
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Quaem Research and Mdical Institute
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh ghasemian Dizaj Mehr
Position
Postgraduate Student of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3711 2488
Fax
Email
ghasemians901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohreh Yousefi
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51318411538
Fax
Email
yousefiz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Gasemian Dizaj Mehr
Position
Postgraduate Student of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Mashhad School of Medicine, Pardis University, Azadi Square, Mashhad, Khorasan Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3711 2488
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)