Comparing the effect of clomiphene & estradiol valerate with letrozole on endometrial thickness, abortion and treatment results in polycystic ovarian infertile women under induction ovulation
The aim of this study is to compare the effect of clomiphene and estradiol valerate with letrozole on endometrial thickness, abortion and treatment results in polycystic ovarian infertile women under induction ovulation. A total of 100 patients with PCOS referring to Besat Hospital infertility clinic were selected and randomly divided into two intervention (two drugs) and control (one drug plus placebo) groups. Inclusion criteria were including; Polycystic ovary syndrome based on Rotterdam Criteria, age between 18 to 48, menstrual disturbances (oligomenorrhea or amenorrhea) , clinical or biochemical hyperandrogenism and exclusion criteria were including; Hyperprolactinemia, thyroid problems, anatomical problem of uterine cavity and fallopian tubes which is approved by hsterosalpingography. Intervention group received 2 clomiphene 50 mg\day from day 3 to day 7 of menstruation and 4 mg estradiol valerate after day 3 to day 14. Control group received 2 ltetrozol 2.5mg/day from day 3 to day 7 of menstruation, for similarity and also blindness of study, placebo was gave to this group. For the two groups at day 14 of the menstrual cycle to evaluate the endometrial thickness transvaginal ultrasound was done by a radiologist. In terms of retarded menstruation BHCG would be checked and if pregnancy was positive they would be followed-up until the third month of the pregnancy. Data will be recorded in a check list.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052612789N11
Registration date:2015-07-11, 1394/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-11, 1394/04/20
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of clomiphene & estradiol valerate with letrozole on endometrial thickness, abortion and treatment results in polycystic ovarian infertile women under induction ovulation
Public title
Comparing the effect of clomiphene and estradiol valerate with letrozole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: polycystic ovary syndrome based on Rotterdam Criteria; age between 18 to 48 years old; menstrual disturbances (oligomenorrhea or amenorrhea); clinical or biochemical hyperandrogenism.
Exclusion criteria: hyperprolactinemia; thyroid problems; anatomical probleb of uterin cavity and fallopian tubes which is approved by hsterosalpingography.
Age
From 18 years old to 48 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sampling was done using blocks of 4 and patients were randomly placed in one of the two groups. The researchers had no role in determining groups and also patients were not aware of grouping.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
Muk.Rec.1393.15
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Day 14 of the menstrual cycle
Method of measurement
Transvaginal ultrasound
2
Description
Pregnancy
Timepoint
One month after the menstrual cycle
Method of measurement
positive BHCG and ultrasound
3
Description
Abortion
Timepoint
Three months (in the case of Pregnancy)
Method of measurement
The patient's medical record
Secondary outcomes
1
Description
Endometrial thickness improvement
Timepoint
On day 14 of the menstrual cycle
Method of measurement
Transvaginal ultrasound
Intervention groups
1
Description
Intervention group received 2 clomiphene 50 mg\day from day 3 to day 7 of menstruation and 4 mg estradiol valerate after day 3 to day 14.
Category
Treatment - Drugs
2
Description
Control group received 2 ltetrozol 2.5mg/day from day 3 to day 7 of menstruation, for similarity and also blindness of study, placebo was gave to this group.