Comparison of pregnancy outcomes in infertile patients with polycystic ovarian syndrome receiving Menogon monotherapy alone and in patients receiving Gonal-F and Menogon for ovulation induction in women
Determination and comparison of pregnancy outcomes in infertile patients with polycystic ovary syndrome receiving monogonal medication alone and patients receiving GonalF and Mannogan for ovulation induction in women referring to Hazrat Zahra clinic of Shahrekord in 1397
Design
Clinical trials without control group, with parallel groups, not blind, not randomized
Settings and conduct
100 infertile PCOS patients who were referred to the Infertility Clinic of Hazrat Zahra Shahrekord in 1997 and were candidates for fertility in the laboratory were selected. The age of women was less than 40 years old. Age, husband's age, duration of infertility, presence of PCOS symptoms, the result of hysterosalpingogram to reject tubal infertility, and the results of laboratory analysis of semen analysis, FSH and LH were collected by the trained midwife of the infertility center and recorded in the checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Polycystic ovary syndrome; Age younger than 40 years; Induction of in vitro fertilization; No response to treatment with clomiphene citrate in patients; Exclusion criteria: Blocking both tubes as the cause of infertility; Hypothalamic amenorrhea as the cause of infertility; Early ovarian failure as the cause of infertility;Infertility due to severe male or azoospermia; Diabetes: Thyroid problems; Kidney disease; Sensitization to letrozole and clomiphene
Intervention groups
Patients are divided into two intervention groups. The group received Monogon alone and the group receiving monogast and gonal
Main outcome variables
The number of ocits earned; Endometrial thickness; Number of cases of empty follicular syndrome; The number of cases of ovarian hyperstimulation syndrome; Human Chorionic Gonadotropin; Fetal heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N10
Registration date:2019-05-07, 1398/02/17
Registration timing:prospective
Last update:2019-05-07, 1398/02/17
Update count:0
Registration date
2019-05-07, 1398/02/17
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-02, 1398/03/12
Expected recruitment end date
2019-10-04, 1398/07/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy outcomes in infertile patients with polycystic ovarian syndrome receiving Menogon monotherapy alone and in patients receiving Gonal-F and Menogon for ovulation induction in women
Public title
Effect of consumption of Gonal-F and Menogan on the fertility of infertile patients with Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infection with polycystic ovary syndrome
Age less than 40 years
Induction of in vitro fertilization
No response to treatment with clomiphene citrate in patients
Exclusion criteria:
Blocking both tubes as the cause of infertility
Hypothalamic amenorrhea as the cause of infertility
Early ovarian failure as the cause of infertility
Infertility due to severe male or azoospermia
Diabetes
Problems with thyroid problems
Kidney Disease
Sensitization to letrozole and clomiphene
Age
To 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.SKUMS.REC.1397.263
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
The number of ocits earned
Timepoint
7 and 12 days after the intervention
Method of measurement
Vaginal ultrasound
2
Description
Endometrial thickness
Timepoint
7 and 12 days after the intervention
Method of measurement
Measurement
3
Description
Number of cases of empty follicular syndrome
Timepoint
7 and 12 days after the intervention
Method of measurement
Vaginal ultrasound
4
Description
The number of cases of ovarian hyperstimulation syndrome
Timepoint
7 and 12 days after the intervention
Method of measurement
Based on the amount of free fluid in the abdomen with ultrasound
5
Description
Human Chorionic Gonadotropin
Timepoint
16 days after the transfer of embryos
Method of measurement
Experiment
6
Description
Fetal heart rate
Timepoint
6 weeks after fertilization
Method of measurement
FHR machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the first group, manogan injections containing 75 units of LH and 75 units of FSH were injected once a day and for 10-12 days.
Category
Treatment - Drugs
2
Description
Intervention group: For the second group, for ovulation stimulation, a gonal-F-containing ampoule containing 75 units of FSH is used subcutaneously for up to 7 days or as long as the follicles reach 12 mm, then the monogonal and gonalophobic Ovulation time is prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zahra clinic of Shahrekord
Full name of responsible person
Maryam Nemati
Street address
Next to the mosque of Imam Hasan, Saadi street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3222 0478
Email
Mertanem@yahoo.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Next to the mosque of Imam Hasan, Saadi street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3222 0478
Email
Mertanem@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Next to the mosque of Imam Hasan, Saadi street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3222 0478
Email
Mertanem@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Next to the mosque of Imam Hasan, Saadi street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3222 0478
Email
Mertanem@yahoo.co.uk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not 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
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Hazrat Zahra clinic of Shahrekord
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.