Evaluation of effect of ovarian stimulation protocol on incidance of luteinized unruptured follicle syndrome in infertile women undergoing induction ovulation and intrauterine insemination
Luteinized unruptured follicle syndrome is considered as a cause of ovulation failure and a subtle cause of infertility. As regard of possibility of interferece of clomiphene citrate on etiology of LUF and so far few stydies have investigated incidence of LUF and relation with follicular size ,hormonal profile (luteal phase progesterone,FSH,LH)and endometial thickness in other ovarian stimulation regimens,this study is designed with purpose of evaluation and comparision of LUF related factors in eligible infertile women undergoing two stimulation protocols (clomiphene+HMG)and (letrozole+HMG)and IUI.A total of 180 infertile women 18-35years old with pco,unexplained or male factor infertility after first routine evaluation are included.patients in two equal groups are administred tablet clomiphene citrate 100mg/d or letrozole 5mg/d orally on 3-7 days of cycle and HMG 75IU/d IM from 8 day of cycle.Patients are monitored by vaginal sonography untile one follicle reaches>> 18mm.Then HCG 10000IU IM is administred and IUI is performed after 38-40 hours.Transvaginal sonography is performed in HCG day ,before IUI and 5-6 days after IUI.According to results of sonographies and luteal phase progesterone ,LUF or ovulation is diagnosed.Then patients are followed 14 days after IUI by βhcg.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091019113N1
Registration date:2014-09-29, 1393/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Mansooreh Pejmanmanesh
Name of organization / entity
Mirza Koochak Khan Hospital-Tehran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21888977614
Email address
m-pejmanmanesh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of ovarian stimulation protocol on incidance of luteinized unruptured follicle syndrome in infertile women undergoing induction ovulation and intrauterine insemination
Public title
effect of ovarian stimulation drugs on incidance of unruptured follicle
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1-infertile women 18-35years old candidate for IUI
2-infertility causes:pco,unexplained infertility,male factor
Exclusion criteria:
1-hyper prolactinemia,hypo and hyperthyroidism,ovarian cyst,NSAID users,uterus and tubal malfprmation
2-OHSS
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
corner of Taleghani St, Ghods St, Keshavarz Boolvar
City
Tehran
Postal code
Approval date
2014-09-03, 1393/06/12
Ethics committee reference number
/ص/93/1202/130
Health conditions studied
1
Description of health condition studied
luteinized unruptured follicle
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
2
Description of health condition studied
luteinized unruptured follicle
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
luteinized unruptured follicle
Timepoint
5-6 days after IUI
Method of measurement
sonography+ serum progesterone( ng/ml)
Secondary outcomes
1
Description
follicular size
Timepoint
every other day from 10 day of cycle
Method of measurement
vaginal sonography
2
Description
serum progesterone
Timepoint
5-6 days after IUI
Method of measurement
blood test
3
Description
ovulation
Timepoint
before and 5-6 days after IUI,
Method of measurement
vaginal sonography
4
Description
pregnancy
Timepoint
14days after IUI
Method of measurement
βhcg blood test
5
Description
FSH
Timepoint
2-3 day of cycle before included in stydy
Method of measurement
blood test
6
Description
infertility cause
Timepoint
before included in study
Method of measurement
clinician judgement
7
Description
Endometrial thickness
Timepoint
every other day from 10 day of cycle
Method of measurement
vaginal sonography
8
Description
LH
Timepoint
2-3day of cycle before included in study
Method of measurement
blood test
Intervention groups
1
Description
Tab clomiphene citrate 100mg/d orally on 3-7 days of cycle in group1
Amp HMG 75IU/d IM from 8 day of cycle in group1
Amp HCG 10000IU IM when follicular diameter >>18mm in group1
Category
Treatment - Drugs
2
Description
Tab letrozole 5mg/d orally on 3-7 days of cycle in group 2
Amp HMG 75IU/d IM from 8 day of cycle in group 2
Amp HCG 10000IU IM when follicular diameter >>18mm in group2
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirza koochak khan Hospital.Tehran Universsity Of Medical Sciences
Full name of responsible person
Dr.Mansooreh Pejmanmanesh Infertility and IVF fellowship assistant
Street address
North Ostad Nejatollahi St, Karimkhan Zand Av,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Dr.Masood Yoonesian
Street address
Central Organization of University, corner of Ghods St, Keshavarz Boolvar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
IVF ward, Mirza Koochakkhan Hospital, Tehran University Of Medical Sciences
Full name of responsible person
Dr.Mansooreh Pejmanmanesh
Position
Infertility fellowship assistant
Other areas of specialty/work
Street address
North Ostad Nejatollahi St, Karimkhan Zand Av
City
Tehran
Postal code
Phone
+98 21 8897 7614
Fax
+98 21 8891 5959
Email
hosp_mirza@tums.Ac.Ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
IVF ward-Mirza Koochakkhan Hospital-Tehran University Of Medical Sciences
Full name of responsible person
Dr.Mansooreh Pejmanmanesh
Position
Infertility fellowship assistant
Other areas of specialty/work
Street address
North Ostad Nejatollahi St-Karimkhan Zand Av
City
Tehran
Postal code
Phone
+98 21 8897 7614
Fax
+98 21 8891 5959
Email
hosp_mirza@tums.Ac.Ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
IVF ward, Mirza Koochakkhan Hospital, Tehran University Of Medical Sciences
Full name of responsible person
Dr.Mansooreh Pejmanmanesh
Position
Infertility fellowship assistant
Other areas of specialty/work
Street address
North Ostad Nejatollahi St, Karimkhan Zand Av
City
Tehran
Postal code
Phone
+98 21 8897 7614
Fax
+98 21 8891 5959
Email
hosp_mirza@tums.Ac.Ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)