Comparison of letrozole alone with letrozole and N-Acetylcysteine for pregnancy rate in polycystic ovary syndrome patient who were undergoune induction
Comparison of letrozole alone with letrozole and N-Acetylcysteine for pregnancy rate in polycystic ovary syndrome patient who were undergoune induction of ovulation
Design
randomized clinical trial with two groups of control and intervention, random sampling without making blind
Settings and conduct
Molood clinic of Zahedan, a randomized clinical trial with sampling method on 162 patients
Participants/Inclusion and exclusion criteria
entry conditions: presence of two of oligo/involution criteria, clinical or laboratory based evidences of hyperendrogenism and polycystic ovaries in sonography, normal thyroid function and prolactin tests, normal fallopian tubes ( by hystrosalpangography), normal semen analysis of the male partner؛
non entry conditions: thyroid and prolactin dysfunction, tubal abnormalities leading to infertility, medium to severe semen fluid abnormalities of sperm quantity, mobility and shape leading to infertility
Intervention groups
patiens are devided randomly into 81 membered control ( letrosol alone) and interventional ( letrosol with n_acetyl cysteine) groups. the control group takes 5mg letrosol daily and interventional group takes 5mg letrosol with 1200mg NAC daily, both from third to seventh days of menstruation. 5 days after the last dose of letrosol; patients are examined on vaginal sonography due to measuring the endometrial thickness, quantity and diameter of matured follicles
Main outcome variables
the effect of Letrozole and the effect of both Letrozole and N-acetylcycteine in patients with polycystic ovarian disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180425039418N2
Registration date:2018-12-15, 1397/09/24
Registration timing:registered_while_recruiting
Last update:2018-12-15, 1397/09/24
Update count:0
Registration date
2018-12-15, 1397/09/24
Registrant information
Name
mohammad Ghena'at Pisheh Sanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 1227
Email address
mohammad.ghenaat71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of letrozole alone with letrozole and N-Acetylcysteine for pregnancy rate in polycystic ovary syndrome patient who were undergoune induction
Public title
Comparison of letrozole alone with letrozole and N-Acetylcysteine for pregnancy rate in polycystic ovary syndrome patient who were undergoune induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
presence of two of oligo/involution criteria
clinical or laboratory based evidences of hyperendrogenism and polycystic ovaries in sonography
Exclusion criteria:
thyroid and prolactin dysfunction
tubal abnormalities leading to infertility
medium to severe semen fluid abnormalities of sperm quantity, mobility and shape leading to infertility
presence of cysts(larger than 6 cm), history of asthma and usage of drugs influencing on glucose metabolism within 3 month before study entrance
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
block: permutational, two groups with 81 members
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 Zahedan University of Medical Sciences
Street address
Medical Sciences Campus, Doctor Hesabi Square,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.ZAUMS.REC.1397.167
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
2
Description of health condition studied
pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the number of pregnancies
Timepoint
since the third day through seventh day after menstruation, 5 mg Letrozole was given to the group of control for 5 days and 5 mg Letrozole and 1200mg N-acetylcycteine were given to the group of intervention
Method of measurement
the structured checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: this randomized clinical trial will be done on patients with poly cystic ovarian disease who randomly will be selected as intervention and control group . the control group will have 5mg Letrozole at the third to seventh day after menstruation for 5 days
Category
Treatment - Drugs
2
Description
Intervention group 2: the intervention group will take 5mg Letrozole with 1200 mg N-acetylcycteine for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Molood clinic
Full name of responsible person
Mohammad Hadi Abbasi
Street address
Ali-Ibne-Abitaleb hospital, KHalij Fars blv,Zahedan,Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
public@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Seyyed Mohammad Hashemi
Street address
Ali-Ibne-Abitaleb hospital, KHalij Fars blv,Zahedan,Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sedigheh Mollashahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali-Ibne-Abitaleb hospital, KHalij Fars blv,Zahedan,Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
salahi13639@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sedigheh Mollashahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali-Ibne-Abitaleb hospital, KHalij Fars blv,Zahedan,Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
salahi13639@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sedigheh Mollashahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ali-Ibne-Abitaleb hospital, KHalij Fars blv,Zahedan,Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
salahi13639@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD