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The effect of dienogest, Oral contraceptive pill(OCP), Decapeptyl treatment, and fresh transfer method after ovum pickup in IVF women candidates on pregnancy outcomes in women with endometriosis

Protocol summary

Study aim
Determining the effect of dienogest, Oral contraceptive pill(OCP), Decapeptyl treatment, and fresh transfer method after ovum pickup in IVF candidate women on pregnancy outcomes
Design
A randomized, non-blinding clinical trial, with parallel groups, Phase 2 on 88 patients
Settings and conduct
In this randomized clinical trial study without blinding, 88 women candidates for IVF referring to Shahid Beheshti and Amin Hospitals of Isfahan will be included in the study and will be randomly divided into four groups. Then, each group is treated with dienogest, oral contraceptive pill(OCP), decapeptyl, and fresh transfer method, respectively. Then the percentage of HCG positivity and endometrial thickness of the patients will be evaluated and compared among the four groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include Infertile women of reproductive age 30-45 years, suffering from endometriosis, IVF candidate, and consent to participate in the study. Exclusion criteria include any drug sensitivity, having a history of thromboembolic diseases, malignancy, positive family history of thrombophilia, prohibition of pregnancy, and having infectious diseases.
Intervention groups
The first intervention group: Patients in this group were treated with dienogest at the rate of 2 mg/kg for 3 months, and then IVF was immediately performed on them. The second intervention group: Patients in this group were treated with oral contraceptive pills (OCP) for 3 months, and then IVF was immediately performed on them. The third intervention group: Patients in this group were treated with decapeptyl 3.75 mg for 3 months. Then 15 days after the last dose, IVF is performed on them. In the fourth intervention group: for patients in this group without receiving the above three drugs, embryo fresh transfer is done.
Main outcome variables
HCG; Clinical pregnancy percentage; Endometrial thickness

General information

Reason for update
Acronym
IVF
IRCT registration information
IRCT registration number: IRCT20220609055118N1
Registration date: 2022-08-30, 1401/06/08
Registration timing: prospective

Last update: 2022-08-30, 1401/06/08
Update count: 0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Shadi Soroushfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3131 8818
Email address
shadisoroushfar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dienogest, Oral contraceptive pill(OCP), Decapeptyl treatment, and fresh transfer method after ovum pickup in IVF women candidates on pregnancy outcomes in women with endometriosis
Public title
The effect of dienogest, Oral contraceptive pill(OCP), Decapeptyl treatment, and fresh transfer method on pregnancy outcomes in women with endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women Reproductive age 30-45 years Suffering from any of the stages 3 or 4 of endometriosis IVF candidate Consent to participate in the study
Exclusion criteria:
Any drug sensitivity History of thromboembolic diseases, malignancy Positive family history for thrombophilia Contraindication of contraceptive use, GnRH agonist Prohibition of pregnancy Having infectious diseases such as hepatitis B, C or HIV
Age
From 30 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 88 eligible patients are randomly selected. For this, the letter A is written on 22 sheets, the letter B is written on 22 sheets, the letter C is written on 22 sheets, and the letter D is written on 22 sheets, and each of them is placed in an envelope. Then each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups.
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 Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-11-20, 1400/08/29
Ethics committee reference number
IR.MUI.MED.REC.1400.643

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Level of human chorionic gonadotropin (B-HCG)
Timepoint
After the intervention
Method of measurement
Urinalysis

2

Description
Endometrial thickness
Timepoint
Before and after the intervention
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: Patients in this group were treated with dienogest at the rate of 2 mg/kg for 3 months, and then IVF was immediately performed on them.
Category
Treatment - Drugs

2

Description
The second intervention group: Patients in this group were treated with oral contraceptive pills (OCP) for 3 months, and then IVF was immediately performed on them.
Category
Treatment - Drugs

3

Description
The third intervention group: patients in this group were treated with decapeptyl 3.75 mg for 3 months; So that they receive a dose of medicine every 28 days. Then 15 days after the last dose, IVF is performed on them.
Category
Treatment - Drugs

4

Description
Fourth intervention group: For patients in this group, without receiving the above three drugs, embryo transfer is done fresh.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hatav Ghasemi Tehrani
Street address
Motahari Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
tehrani@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
tehrani@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
tehrani@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Soroushfar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
6 floor, Nikan build, Al-khojand st. , Soroush ave.
City
Isfahan
Province
Isfehan
Postal code
813991111
Phone
+98 31 3131 8818
Fax
Email
Shadisoroushfar@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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