Comparison of ovulation induction with clomiphene and letrozole versus clomiphene and hormone
Human gonadotropin in clomiphene-resistant patients with polycystic ovary syndrome
Design
Clinical trial with parallel groups of phase 2 on 120 patients
Settings and conduct
Patients will be sampled from the infertility center of Akbarabadi Hospital and the professors' office. The first group would be treated with a combination of clomiphene 100 mg from day 5 to 11and letrzol 5 mg daily from day 5 to 9 of menstruation. On the 16th day of menstruation, they will be examined by transvaginal ultrasound. If there will be at least one follicle above 18 mm, HCG injection will be prescribed. The second group will be treated with a combination of clomiphene 100 mg daily from day 3 to 7 of menstruation and ampoules of human gonadotropin on days 6, 7 and 8 of menstruation. On the 18th day, they will be examined by transvaginal ultrasound and if there will be a follicle above 18 mm HCG, it will be prescribed for final induction.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women18 to 40 years old with infertility of more than one year, without significant underlying disease, with one or two open fallopian tubes, normal spermogram.
Exclusion Criteria: age group out of range, hypo or Hyperthyroidism. Hyperprolactinemia. Anatomical problems of the uterus and fallopian tubes.
Intervention groups
The two intervention groups included women with one-year infertility who are resistant to clomiphene, one group will receive clomiphene and human gonadotropin, and the second group will receive clomiphene and letrozole.
Main outcome variables
Endometrial thickness; Pregnancy rate; Number of follicles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211120053119N1
Registration date:2022-01-29, 1400/11/09
Registration timing:registered_while_recruiting
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
Maryam Dadkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 8189
Email address
mdadkhah27@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of aromatase inhibitor with human gonadotropin in patients with clomiphene-resistant polycystic ovary syndrome
Public title
Comparison of effects of an aromatase inhibitor with human gonadotropin in clomiphene-resistant polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with more than one year of infertility and clomiphene resistant polycystic ovary syndrome
No significant underlying disease
Has one or two open fallopian tubes
Spouse normal spermogram
Exclusion criteria:
Age out of range
Hypo or hyperthyroidism
Hyperprolactinemia
Anatomical problems of the uterus and fallopian tubes
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not 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 Iran University of Medical Sciences
Street address
Tehran, Hemat Highway next to Milad Tower , 14535
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.IUMS.FMD.REC.1398.329
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome, infertility
ICD-10 code
سندرم تخمد
ICD-10 code description
سندرم تخمدان پلی کیستیک
Primary outcomes
1
Description
Number of follicles
Timepoint
On the 16th Day of the menstrual cycle
Method of measurement
Vaginal ultrasound machine
2
Description
Pregnancy rate
Timepoint
one month
Method of measurement
blood test
3
Description
Endometrial Thickness
Timepoint
On the 16th Day of the menstrual cycle
Method of measurement
Vaginal ultrasound machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the first step, Patients with induce ovulation were treated with clomiphene (50mg tablet produced by Iran Hormone Company), 100 mg daily from the 5th day of menstruation for 5 days, as well as on the 14th day of the ultrasound cycle. Even by prescribing clomiphene 150 mg for 7 days, patients still have not ovulated. In this study, these patients were considered clomiphene resistant patients and were divided into two equal groups of 60, each of them was placed in one of these two groups. The first group of patients was treated with a combination of clomiphene 100 mg from day 5 to 11 and letrozole 5 mg daily from day 5 to 9 of menstruation. On the 16th day of menstruation, transvaginal ultrasound was performed to check the number and size of follicles. Depending on the patient's condition, if there is at least one follicle above 18 mm, then 1 or 2 ampoules of HCG were prescribed for the final induction of ovulation.
Category
Treatment - Drugs
2
Description
Intervention group: The second group of pateints was treated with a combination of clomiphene 100 mg daily from day 3 to 7 and ampoules of human gonadotropin hormone (ampoule 75 units produced by Karma company) on days 6, 7 and 8 of menstruation. The next doses were adjusted according to the patient's response. On day 18, transvaginal ultrasound was performed to check the size and number of follicles, and patient's condition, if there is at least one follicle above 18 mm, then 1 or 2 ampoules of HCG were prescribed for the final induction of ovulation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Akbarabadi Hospital and Dr. Ashrafi's office
Full name of responsible person
Maryam Dadkhah
Street address
Tehran, Hemat Highway next to Milad Tower , 14535
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2220
Email
mdadkhah27@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Dadkhah
Street address
Tehran, Hemat Highway next to Milad Tower , 14535
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2220
Email
mdadkhah27@yahoo.com
Grant name
Vice Chancellor for Research, Iran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
2
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Irani
Street address
Tehran, Hemat Highway next to Milad Tower , 14535
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2220
Email
Education@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Dadkhah
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran, Hemat Highway next to Milad Tower , 14535
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2220
Email
mdadkhah27@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Ashrafy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 2.Royan Alley, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
8183367898
Phone
+98 21 8895 5725
Email
ashrafi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Dadkhah
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 6, Mahtab commercial , Ghadir Blvd
City
Isfahan
Province
Isfehan
Postal code
81799441898
Phone
+98 31 3651 8189
Email
mdadkhah27@ yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' data such as age, duration of infertility, type of infertility could be shared.
When the data will become available and for how long
Access starts 6 months after publishing results
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
To find out more about continuing the pregnancy
From where data/document is obtainable
Visit mdadkhah27@yahoo.com
What processes are involved for a request to access data/document
After sending the request to the applicant and reviewing the records, it will be sent via email about a month later.