Comparison of live births rate in four method of ovarian stimulation in patients with polycystic ovarian syndrome.
Design
A randomized clinical trial with control group, open label, four arm parallel group design of 120 patients. Randomization is performed using a computer-generated random assignment schedule for each patient. Sealed and numbered envelopes are used to conceal the treatment allocation until randomization.
Settings and conduct
Female infertility Clinic of ROYAN institute
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Infertile women with polycystic ovarian syndrome based on Rotterdam criteria; age 20-38 years; body mass index Less than 30 Kg/m2. Conditions for not entering the study: Women with hematologic and autoimmune disorders; couples with chromosomal and genetic abnormalities; women with uterine anomalies; women with uterine and ovaries surgical history; women with endometriosis and adenomyosis; women with hydrosalpinx; women with uterine fibroids; severe male factor infertility (azoospermia); women with recurrent abortion history; women with recurrent implantation failure history.
Intervention groups
Intervention groups:
1. The group of minimal ovarian stimulation with recombinant FSH
2. The group of minimal ovarian stimulation with Human Menopausal Gonadotropin
Control groups:
1. The group of mild ovarian stimulation with recombinant FSH
2. The group of mild ovarian stimulation with Human Menopausal Gonadotropin
Main outcome variables
Live births rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080831001141N30
Registration date:2020-12-23, 1399/10/03
Registration timing:retrospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2016-11-12, 1395/08/22
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2019-05-30, 1398/03/09
Scientific title
The comparison of four methods of ovarian stimulation with GnRH antagonist in patients with polycystic ovarian syndrome
Public title
Mild and minimal ovarian stimulation in patients with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with polycystic ovarian syndrome based on Rotterdam criteria
Age 20-38 years
Body Mass Index less than 30 Kg/m2
Exclusion criteria:
Women with hematologic and autoimmune disorders
Couples with chromosomal and genetic abnormalities
Women with uterine anomalies
Women with uterine and ovaries surgical history
Women with endometriosis and adenomyosis
Women with hydrosalpinx
Women with uterine fibroids
Severe male factor infertility (azoospermia)
Women with recurrent abortion history
Women with recurrent implantation failure history
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 8. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 120 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
مرکز ثبت کارآزمایی های بالینی ایالات متحده امریکا (WWW.clinicaltrial.gov)
Secondary trial Id
NCT03876145
Registration date
2019-03-15, 1397/12/24
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2016-10-18, 1395/07/27
Ethics committee reference number
IR.ACECR.ROYAN.REC.1395.82
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Live birth rate; live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational.
Timepoint
Only once; at least 20 weeks after embryo transfer.
Method of measurement
Clinical information.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group of minimal ovarian stimulation with recombinant FSH. In this group, patients will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Gonal-f (Follitropin alfa, Merck Serono, Germany) after the seventh day.
Category
Treatment - Other
2
Description
Intervention group: The group of minimal ovarian stimulation with human menopausal gonadotropin. In this group, patients will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Merional (Highly Purified Menotropin، IBSA، Switzerland) after the seventh day.
Category
Treatment - Other
3
Description
Control group: The group of mild ovarian stimulation with recombinant FSH. In this group, patients that will receive 150 IU Gonal-f daily from Day 3 of the menstrual cycle.
Category
Treatment - Other
4
Description
Control group: The group of mild ovarian stimulation with human menopausal gonadotropin. In this group, patients that will receive 150 IU Merional daily from Day 3 of the menstrual cycle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of ROYAN
Full name of responsible person
Firouzeh Ghaffari
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
ghafaryf@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ROYAN Institute
Full name of responsible person
Parvaneh Afsharian
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ROYAN Institute
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Firouzeh Ghaffari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
ghafaryf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Firouzeh Ghaffari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
ghafaryf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Firouzeh Ghaffari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
ghafaryf@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report (published article)
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Available to the public.
Under which criteria data/document could be used
Scientific use by citing the source.
From where data/document is obtainable
Dr. Firehouse Ghaffari
Email: ghafaryf@yahoo.com
What processes are involved for a request to access data/document