Fertility outcome of hyperprolactinemic infertile women undergoing induction of ovulation for intrauterine insemination (IUI): A comparison between Bromocriptine and Cabergoline
The aim of this study was to compare the effects of bromocriptine versus cabergoline on pregnancy outcomes in hyperprolactinaemic infertile women. We included hyperprolactinaemic infertile women with or without galactorrhea (prolactin>20 ng/ml) and the major exclusion criteria were other causes of infertility in both couples and any treatment side effects. A total number of 183 infertile women with hyperprolactinemia undergoing intrauterine insemination (IUI) were randomly divided into two groups. Group A: 94 patients under the treatment of bromocriptine 2.5 mg BID and group B: 89 patients under the treatment of cabergoline 0.25 mg twice a week. Induction of ovulation was started when prolactin level became normal. Vaginal sonography was performed on the day 10th or 11th of cycle and according to the size and number of stimulated follicles, HMG was continued till at least 2 dominant follicles with size of >18 mm were seen. If this condition was not achieved, HMG was discontinued and it was restarted from the next cycle. IUI was performed 24-36 hours after swim-up method. Pregnancy was documented by transvaginal sonography, at 6-7 weeks of gestational age. Main outcome measurements were serum prolactin level, disappearance of galactorrhea, regulation of menses, side effects of both medication and the occurrence of pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806142420N1
Registration date:2009-10-25, 1388/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-10-25, 1388/08/03
Registrant information
Name
Seyed-Mohammad Fereshtehnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2275 6035
Email address
mohammad@stu.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Shiraz University of Medical Sciences
Expected recruitment start date
2005-03-01, 1383/12/11
Expected recruitment end date
2007-03-01, 1385/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fertility outcome of hyperprolactinemic infertile women undergoing induction of ovulation for intrauterine insemination (IUI): A comparison between Bromocriptine and Cabergoline
Public title
Comparison of the effects of Bromocriptine and Cabergoline on the occurrence of pregnancy in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Primary or secondary infertility, 2) Hyperprolactinemia with or without galactorrhea (prolactin>20ng/ml), 3) Normal HA except high prolactin level, normal HSG or laparoscopy and normal SA.
Exclusion criteria: 1) other causes of infertility such as tubal factor, male factor or unexplained infertility, 2) nausea, vomiting, orthostatic hypotension, chronic hypertension, headache, 3) sensitivity to ergot derivatives, 4) macroadenoma of pituitary gland, 5) previous use of bromocriptine or cabergoline
Age
From 19 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
188
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Research deputy, 7th floor, Central department of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Approval date
2007-04-21, 1386/02/01
Ethics committee reference number
CT-86-3330
Health conditions studied
1
Description of health condition studied
Hyperprolactinemic infertile women
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
The occurrence of pregnancy
Timepoint
At 6-7 weeks of gestational age
Method of measurement
Transvaginal sonography
Secondary outcomes
1
Description
Serum prolactin level
Timepoint
4 weeks after treatment
Method of measurement
Laboratory measurment
2
Description
Treatment side effects
Timepoint
Every 4 weeks
Method of measurement
Check list
Intervention groups
1
Description
Bromocriptine 2.5 mg BID
Category
Treatment - Drugs
2
Description
Cabergoline 0.25 mg twice a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeinabiyeh Hospital
Full name of responsible person
Street address
Sarbaz Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hosein Dabbaghmanesh
Street address
Research Deputy, 7th floor, Central department of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Shiraz 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
Iran University of Medical Sciences and Health Services
Full name of responsible person
Seyed-Mohammad Fereshtehnejad
Position
General physician, Student of MPH
Other areas of specialty/work
Street address
Medical Faculty, Iran University of Medical Sciences and Health Services, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 2275 6035
Fax
Email
mohammad@stu.iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Lida Babakhani
Position
Gynecologist
Other areas of specialty/work
Street address
Research Deputy, Central department of Shiraz University of Medical Sciences and Health Services, Zand St.
City
Shiraz
Postal code
Phone
+98 21 2230 1913
Fax
Email
dr_lida_babakhani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences and Health Services
Full name of responsible person
Seyed-Mohammad Fereshtehnejad
Position
General physician, Student of MPH
Other areas of specialty/work
Street address
Medical Faculty, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Phone
+98 21 2275 6035
Fax
Email
mohammad@stu.iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)