The Effect of Letrozole and Dexamethasone on pregnancy outcome in Poly cystic ovarian syndrome patients candidate for intra uterine insemination: Randomized Clinical trial
The Effect of Letrozole and Dexamethasone on ovulation and pregnancy outcome in patients with polycystic Ovarian Syndrome
Design
A prospective , randomized, single blind clinical trial with two arm parallel group design consisited of 100 infertile poly cystic ovarian syndrome patients. Randomisation was done using computer with concealed randomization sequence. Phase of trial is 1-2
Settings and conduct
This study was done on patients who referred to Milad infertility center .
Group A received Letrozole from 3th day of their cycle for 5 days and group B received 5 mg Letrozole from 3th day of their cycle for 5 days and 0.5 mg Dexamethazon for 10 days.
Serum hormones level (LH, Estradiol , Androstenedion, testosterone ) and folliculogenesis were assessed in all patients.
When the dominant follicles reached 18 mm in diameter ovulation was triggered with 5000Iu IM hCG. IUI was performed 36 hours later. Pregnancy test was done after 14 days. Statistician analyzed data without any information about the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women at the age of 20-35 years old; having at least one patent Fallopian tube; normal sperm analysis of spouse.
Exclusion criteria: smoking; underlying disease ( heart, kidney, liver or Endocrine disease )
Intervention groups
Group A received Letrozole tablet from third day of cycle for 5 days and group B received Letrozole tablet from third day of cycle for 5 days and Dexamethazon tablet 0.5 mg for 10 days.
Serum hormones level (LH, Estradiol , Androstenedion, testosterone ) and folliculogenesis were monitored in patients.
Ovulation was triggered with hCG (5000Iu) when the dominant follicles reached 18 mm in diameter. Intra uterine insemination (IUI) was performed 36 hours later.
Main outcome variables
hormones including luteinizing hormone, estradiol , androstenedion and testostrone; pregnancy rate .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170315033085N4
Registration date:2018-07-29, 1397/05/07
Registration timing:retrospective
Last update:2018-07-29, 1397/05/07
Update count:0
Registration date
2018-07-29, 1397/05/07
Registrant information
Name
malihe afiat
Name of organization / entity
Mashhad medical school
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
afiatm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-02-03, 1391/11/15
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
2013-04-09, 1392/01/20
Actual recruitment end date
2014-04-19, 1393/01/30
Trial completion date
empty
Scientific title
The Effect of Letrozole and Dexamethasone on pregnancy outcome in Poly cystic ovarian syndrome patients candidate for intra uterine insemination: Randomized Clinical trial
Public title
letrozole and Dexametazon effect in Poly cystic ovarian syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
AGE: 25-35 years
at least one patent Fallopian tube
normal sperm analysis of spouse
presence of poly-cystic ovarian syndrome
Exclusion criteria:
Smoking
underlying disease ( heart, kidney, liver or Endocrine)
Age
From 20 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
Data analyser
Sample size
Target sample size:
106
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Data was sent in form of two Group ( A and B ) to the person responsible for data analysis and analyzer wasn't not aware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoraishi department, Daneshgah Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91897-95-96
Approval date
2013-02-02, 1391/11/14
Ethics committee reference number
IR.MUMS.REC.1391.803
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Luteinizing hormone
Timepoint
Third and 12th day of menstrual cycle
Method of measurement
laboratory Test
2
Description
Testestron
Timepoint
Third and 12th day of menstrual cycle
Method of measurement
laboratory Test
3
Description
Anderestandion
Timepoint
Third and 12th day of menstrual cycle
Method of measurement
laboratory Test
4
Description
Esteradiol
Timepoint
Third and 12th day of menstrual cycle
Method of measurement
laboratory Test
5
Description
Pregnancy
Timepoint
14 days after Intrauterine insemination
Method of measurement
laboratory Test, pregnancy test
Secondary outcomes
1
Description
Dominant follicles
Timepoint
12th day of Menestural cycle
Method of measurement
vaginal Sonography
2
Description
Endometrium thickness
Timepoint
12th day of Menestural cycle
Method of measurement
vaginal Sonography
Intervention groups
1
Description
Control group: group A received letrozole tablet ( abouraihan , Iran ) 5 mg from day 3 of menstrual cycle for 5 days .They were monitored hormonal and Sonographical on day 3 and day 12 of cycle. Ovulation was triggered with injection 5000 Iu HCG (karma, Germany ) when the dominant follicle reached 18 mm in diameter. A single IUI was performed 36 hours later. The Luteal phase was supported with the progesterone suppository ( Cyclogest, 400 mg , Actavis, UK) . pregnancy test was don 14 day later.
Category
Treatment - Drugs
2
Description
Intervention group: group B received letrozol 5 mg(Abouraihan-Iran) from 3th day of menstrual cycle for 5 days plus Dexamethazon tablet 0.5 mg (Iran hormone) for 10 days. They were monitored hormonal and Sonographical on day 3 and day 12 of cycle. Ovulation was triggered with injection 5000 Iu HCG (karma, Germany ) when the dominant follicle reached 18 mm in diameter. A single IUI was performed 36 hours later. The Luteal phase was supported with the progesterone suppository ( Cyclogest, 400 mg , Actavis, UK) . pregnancy test was don 14 day later.