The randomized, single -blinded clinical trial comparing OCP effect before frozen embryo transfer versus gonadotropin – releasing hormone agonist injection on improving the outcome of pregnancy in infertile patients with hyper androgenic poly-cystic ovary syndrome in the IVF/ICSI cycle
Investigation the effect of OCP with GNRH agonist on improving pregnancy outcome in patients with hyper androgenic polycystic ovarian disease (PCOD).
Design
In this study, 120 infertile patients with hyper androgenic PCOD after signing informed consent assessing inclusion and exclusion criteria will recruit to study and will be randomly divided into two groups A&B. Patients in group A receive OCP before frozen- thawed embryo transfer and patients in the group B receive GNRH agonist. Pregnancy outcome will be evaluated after embryo transfer in two groups.
Settings and conduct
The location of the study will be the infertility ward in Dr Shariati Hospital. This is a single-blind trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Sign the informed consent form, Patients with hyper androgenic polycystic ovary syndrome based on Rotterdam 2003. Exclusion criteria: Patients with hyper- anderogenism caused by drugs or congenital adrenal hyperplasia or who have been suspected of having Cushing's syndrome or an androgen – secreting neoplasm, known sever organ dysfunction or mental illness, being pregnant or being in post- miscarriage period, being in post- partum period, breastfeeding, being in the 6 weeks after delivery.
Intervention groups
Patients in group A will receive the OCP before frozen- thawed embryo transfer
(Rokinz LD) for 2 months. Patients in group B will receive GNRH agonist (Luprolide acetate 3.75 mg) every 4 weeks for a total of two doses. Hormone therapy for both groups will be started with 8 mg estradiol valerate orally per day for 14 days.
Main outcome variables
The endometrial thickness, the implantation rate, the clinical pregnancy rate, the live birth rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N17
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2020-01-05, 1398/10/15
Update count:0
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The randomized, single -blinded clinical trial comparing OCP effect before frozen embryo transfer versus gonadotropin – releasing hormone agonist injection on improving the outcome of pregnancy in infertile patients with hyper androgenic poly-cystic ovary syndrome in the IVF/ICSI cycle
Public title
Effect of treatment by OCP on infertility in PCOD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Oligo ovulation or anovulation.
Clinical and/or biochemical signs of hyper- androgenism.
Polycystic ovaries.
Exclusion criteria:
Patients with hyper- anderogenism caused by hormonal drugs or other medications.
Patients who have known sever organ dysfunction or mental illness.
Pregnant women or being in Post- miscarriage period.
breastfeeding.
being in the 6 week postpartum period.
Patients had congenital adrenal hyperplasia or were suspected of having Cushing s syndrome or an androgen – screening neoplasm.
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The computer gives each patient a code number. And the code numbers are then allocated to the treatment groups A (OCP receiver) and B (GNRH agonist receiver). In this study, neither the participants nor the researchers know which participants belong to the placebo group, nor the intervention group. Only after all data have been recorded do the person not involved in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The computer gives each patient a code number. And the code numbers are then allocated to the treatment groups A (OCP receiver) and B (GNRH agonist receiver). In this study, neither the participants nor the researchers know which participants belong to the placebo group, nor the intervention group. Only at the end of the study, the results are reported by a person not involved in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University Medical Sciences
Street address
Ethics Committee of Tehran University of Medical Sciences, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.531
Health conditions studied
1
Description of health condition studied
Patients with hyper androgenic polycystic ovarian disease
ICD-10 code
Female inf
ICD-10 code description
N97.0
Primary outcomes
1
Description
Endometrium thickness
Timepoint
Before starting treatment and embryo transfer.
Method of measurement
Trans vaginal ultra-sonography
2
Description
The number of positive chemical pregnancy test
Timepoint
14 days after embryo transfer
Method of measurement
Laboratory test (BHCG over than 40 IU)
3
Description
The number of successful clinical pregnancy
Timepoint
6 to 8 weeks after embryo transfer
Method of measurement
Fetal Heart in Trans vaginal ultrasonography
4
Description
Miscarriage rate
Timepoint
Abortion before 12 weeks of pregnancy
Method of measurement
Fetal death before 12 weeks in ultrasonography.
Secondary outcomes
1
Description
Live birth rate
Timepoint
At 28th week of pregnancy
Method of measurement
Trans abdominal ultrasonography
Intervention groups
1
Description
Intervention group: Receive of the OCP (Rokinz LD), daily 2 months before frozen- thawed embryo transfer.
Category
Treatment - Drugs
2
Description
Control group: Receive depot preparation of the GNRH agonist (Luprolide acetate 3.75 mg) before frozen- thawed embryo transfer, one dose every 4 weeks, totally two doses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Ward, Dr shariati Hospital
Full name of responsible person
Shima Tavakolian
Street address
Infertility Ward, Dr shariati Hospital, North Kargar, Tehran Town.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 84901
Fax
+98 21 8822 0050
Email
asamaei@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Tehran University of Medical Sciences.
Full name of responsible person
Dr Mohammad Ali Sahraeian
Street address
Tehran University of Medical Sciences, Qods Avenue, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3623
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shima Tavakolian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Science. Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 84901
Fax
+98 21 8822 0050
Email
asamaei@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Tavakolian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Science. Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 84901
Fax
+98 21 8822 0050
Email
asamaei@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Tavakolian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Science. Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 84901
Fax
+98 21 8822 0050
Email
asamaei@razi.tums.ac.ir
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
All data is published after being unidentified.
When the data will become available and for how long
starting 24 months after publication.
To whom data/document is available
Infertility researchers.
Under which criteria data/document could be used
Submith a valid academic Certificate.
From where data/document is obtainable
Send email to: hamed_m97@yahoo.com
What processes are involved for a request to access data/document