Assessment of the effect of bromocriptine plus medroxyprogesterone compared with medroxyprogesterone plus placebo on size and clinical symptoms associated with endometrioma.
Design
a double-blinded, phase 2 randomized clinical trial with parallel groups,
60 patients, with ovarian endometrioma, will be randomly assigned into two groups of medroxyprogesterone with Bromocriptine and medroxyprogesterone with placebo via the block randomization method.
Settings and conduct
This study will be carried out on 60 patients with ovarian endometrioma at Shiraz Madar o Kodak Hospital, After random allocation, They will receive medroxyprogesterone with Bromocriptine and medroxyprogesterone with placebo twice daily for 3 months. Endometrioma size, Dysmenorrhea, Dyspareunia will be compared before and at the end of three months. The researcher and statistician will be unaware of how the interventions are allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Having informed consent, definitive diagnosis of endometrioma, Exclusion criteria include: patients with hyperprolactinemia, People with coagulation disorders, who have contraindications to medroxyprogesterone
Intervention groups
intervention group: received medroxyprogesterone 20 mg with Bromocriptine 1.25 mg twice daily for 3 months. Control group: received medroxyprogesterone 20 mg with placebo twice daily for 3 months.
Main outcome variables
Endometrioma size, Dysmenorrhea, Dyspareunia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140802018655N6
Registration date:2021-01-06, 1399/10/17
Registration timing:retrospective
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
Tahereh Poordast
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
poordast@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of therapeutic effect of dopamine agonist (bromocriptine) on endometrioma size
Public title
The effect of bromocriptine on endometrioma size
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A definitive diagnosis of endometrioma
Exclusion criteria:
patients with hyperprolactinemia
People with coagulation disorders
who have contraindications to medroxyprogesterone
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size was 60 participants (30 people in each group). The block randomization method was developed by an epidemiologist collaborator using version 13 of Stata software. To conceal the random allocation process, 60 treatment cards were written in sequential order, then the cards were placed in sealed envelopes. On each envelope, a random code was written with no sequences that only the methodologist was aware of the code. When the physician announced a patient's eligibility, the methodologist provided the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who evaluated the final outcomes was unaware of the random allocation process and the type of treatment performed. Data were analyzed by a statistical expert who was separated from the study process and unaware of all the processes performed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-07-27, 1399/05/06
Ethics committee reference number
IR.SUMS.REC.1399.979
Health conditions studied
1
Description of health condition studied
Endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
endometrioma size
Timepoint
Before transplantation and at the end of 3 months
Method of measurement
Ultrasonography
2
Description
Pain pelvic
Timepoint
Before transplantation and at the end of 3 months
Method of measurement
VAS test
Secondary outcomes
1
Description
Dysmenorrhea
Timepoint
Before transplantation and at the end of 3 months
Method of measurement
VAS test
2
Description
Dyspareunia
Timepoint
Before transplantation and at the end of 3 months
Method of measurement
VAS test
Intervention groups
1
Description
Intervention group: Received medroxyprogesterone 20 mg with Bromocriptine 1/25 mg twice daily for at least 3 months
Category
Treatment - Drugs
2
Description
Control group: Received medroxyprogesterone 20 mg twice daily with placebo for at least 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madar o Kodak Hospital
Full name of responsible person
Tahereh Poordast
Street address
Madar o Kodak Hospitall, Emam Reza Boulevard
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3233 2365
Fax
+98 71 3233 2365
Email
ta.poordast@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸-۱۴۳۳۶
Phone
+98 71 3230 5410
Email
poshtoff@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Poordast
Position
Fellow ship of Infertility and Laparoscopy
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Madar o Kodak Hospitall, EmamReza Boulevard
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 4596
Email
ta.poordast@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Poordast
Position
Fellow ship of Infertility and Laparoscopy
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Madar o Kodak Hospitall, Emam Reza Boulevard
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3233 2365
Email
ta.poordast@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Parizad nassirkandi
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Madar o Kodak Hospitall, EmamReza Boulevard
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3233 2365
Email
parizad116@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Study data is accessible by observing moral points of view on the confidentiality of patient information.
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
Gynecology specialists in coordination with the presenter
Under which criteria data/document could be used
Meta-analysis is allowed on the data of this study.