1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of oral progesterone and vaginal progesterone on luteal phase support using available drugs in IVF/ICSI candidates

View the latest revision

History
# Registration date Revision Id
2 2022-10-12, 1401/07/20 242705
1 2021-11-14, 1400/08/23 205352
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Recruitment centers

    #1
    Name of recruitment center - English: درمانگاه IVF بیمارستان آیت الله موسوی زنجان
    Name of recruitment center - Persian: IVF clinic of Ayatollah mousvi hospital of Zanjan
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Street address - English: IVF clinic, Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, Zanjan, Iran.
    Street address - Persian: زنجان- جاده گاوازنگ - مرکز آموزشی درمانی تخصصی و فوق تخصصی آیت ا... موسوی - درمانگاه IVF
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: ۵۶۱۸۳- ۴۵۱۳۹
    Phone: +98 24 3313 0000
    Fax:
    Email: Mousavihospital@zums.ac.ir
    Web page address:
    Name of recruitment center - English: IVF clinic of Ayatollah mousvi hospital of Zanjan
    Name of recruitment center - Persian: درمانگاه IVF بیمارستان آیت الله موسوی زنجان
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Street address - English: IVF clinic, Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, Zanjan, Iran.
    Street address - Persian: زنجان- جاده گاوازنگ - مرکز آموزشی درمانی تخصصی و فوق تخصصی آیت ا... موسوی - درمانگاه IVF
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: ۵۶۱۸۳- ۴۵۱۳۹
    Phone: +98 24 3313 0000
    Fax:
    Email: Mousavihospital@zums.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Position - English: Senior resident of obstetric and gynaecology
    Position - Persian: رزیدنت بیماریهای زنان و زایمان
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 132, East Baharestan tower, Aseman towers complex, Sina avenue, Elgoli district, Tabriz, East Azerbaijan
    Street address - Persian: آذربایجان شرقی، تبریز، ال گلی، مجتمع برجهای آسمان، بهارستان شرقی، واحد 132
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5167747899
    Phone: +98 41 3331 9585
    Mobile: +98 914 402 4703
    Fax:
    Email: nazlighamari@zums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Position - English: Senior resident of obstetric and gynaecology
    Position - Persian: رزیدنت بیماریهای زنان و زایمان
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Gavazang bimarestane mousavi
    Street address - Persian: بلوار گاوازنگ بيمارستان موسوي
    City - English: Tabriz
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4513986961
    Phone: +98 24 3313 0001
    Mobile: +98 914 402 4703
    Fax:
    Email: nazlighamari@zums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Position - English: Medical Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 132, East Baharestan tower, Aseman towers complex, Sina avenue, Elgoli district, Tabriz, East Azerbaijan
    Street address - Persian: آذربایجان شرقی، تبریز، ال گلی، مجتمع برجهای آسمان، بهارستان شرقی، واحد 132
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5167747899
    Phone: +98 41 3331 9585
    Mobile: +98 914 402 4703
    Fax:
    Email: nazlighamari@zums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Position - English: Medical Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Gavazang bimarestan mousavi
    Street address - Persian: گاوازنگ بيمارستان موسوي
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4513986961
    Phone: +98 24 3313 0001
    Mobile: +98 914 402 4703
    Fax:
    Email: nazlighamari@zums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Position - English: Senior resident of obstetric and gynaecology
    Position - Persian: رزیدنت بیماریهای زنان و زایمان
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 132, East Baharestan tower, Aseman towers complex, Sina avenue, Elgoli district, Tabriz, East Azerbaijan
    Street address - Persian: آذربایجان شرقی، تبریز، ال گلی، مجتمع برجهای آسمان، بهارستان شرقی، واحد 132
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5167747899
    Phone: +98 41 3331 9585
    Mobile: +98 914 402 4703
    Fax:
    Email: nazlighamari@zums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nazli Ghamari
    Full name of responsible person - Persian: نازلی قمری
    Position - English: Senior resident of obstetric and gynaecology
    Position - Persian: رزیدنت بیماریهای زنان و زایمان
    Latest degree: med_doctor
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Gavazanh bimarestan mousavi
    Street address - Persian: گاوازنگ بيمارستان موسوي
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4513986961
    Phone: +98 24 3313 0001
    Mobile: +98 914 402 4703
    Fax:
    Email: nazlighamari@zums.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison of the effect of oral progesterone and vaginal progesterone on luteal phase support using available drugs in IVF/ICSI candidates
Design
160 participant are divided randomly in to two groups of 80 who are administered oral or vaginal progesterone as an luteal phase support. The randomization is performed using random allocation rule.
Settings and conduct
the study will be hold in IVF clinic in Ayatollah mousavi hospital. each participant is administered with either vaginal or oral progesterone as a luteal phase support and the pregnancy out come is compared between two group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. IVF/ICSI candidates 2. age between 18 to 40 years old 3. available informed written consent exclusion criteria: 1. history of drug reaction to drugs used in this study 2. endometriosis 3. Partner azospermia 4. Uterine anatomical anomaly 5. endocrine or metabaolic disorder 6. 2 or more unsuccessful IVF or FET 7. repetitive spontaneous abortion
Intervention groups
Vaginal or oral progesterone is administered in two different groups as an luteal phase support
Main outcome variables
successful pregnancy Unsuccessful pregnancy ( abortion or preterm labor)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211101052938N1
Registration date: 2021-11-14, 1400/08/23
Registration timing: prospective

Last update: 2022-10-12, 1401/07/20
Update count: 1
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Nazli Ghamari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
nazlighamari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-02, 1400/09/11
Expected recruitment end date
2022-03-31, 1401/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral progesterone and vaginal progesterone on luteal phase support using available drugs in IVF/ICSI candidates
Public title
Comparison of the effect of oral progesterone and vaginal progesterone on luteal phase support
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
IVF/ICSI candidate with history of infertility age between 18 to 40 years old have an informed consent to participate in the study
Exclusion criteria:
drug reaction history to one of the drugs used in this study endocrine or metabolic disorders endometriosis Azospermia of partner uterine anatomic anomaly history of 2 or more unsuccessful IVF or FET history of repetitive spontaneous abortion
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
For randomized categorization of the participants we use random allocation rule. 160 participants are divided randomly in to two even groups of 80; case group and control group. The written name of participants are put in the accordant bowl randomly and without replacement and subsequent random sequence will be made.
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 committe of Zanjan university of medical sciences
Street address
Azadi Blv, Zanjan university of medical sciences, Postal code: 4515613191
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
Ir.Zums.REC.1400.346

Health conditions studied

1

Description of health condition studied
In vitro fertilization
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percent of successful pregnancy following in vitro fertilization
Timepoint
Evaluating the outcome of pregnancies at the end of the study
Method of measurement
Recording the successful and unsuccessful pregnancy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in this group 400 mg vaginal progesterone (Fertigest 400 mg vaginal of Aburaihan ‌Pharmaceutical Co)is prescribed for luteal phase support.
Category
Treatment - Drugs

2

Description
Control group: In this group Dofamed 10 mg (Atipharmed Pharmaceutical Company) is prescribed orally three times a day for luteal phase support.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
IVF clinic of Ayatollah mousvi hospital of Zanjan
Full name of responsible person
Nazli Ghamari
Street address
IVF clinic, Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, Zanjan, Iran.
City
Zanjan
Province
Zanjan
Postal code
۵۶۱۸۳- ۴۵۱۳۹
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Ganji
Street address
Zanjan University of Medical Sciences , Dr.Sobouti Blvd. Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6176
Email
aganji@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Nazli Ghamari
Position
Senior resident of obstetric and gynaecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gavazang bimarestane mousavi
City
Tabriz
Province
Zanjan
Postal code
4513986961
Phone
+98 24 3313 0001
Email
nazlighamari@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nazli Ghamari
Position
Medical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gavazang bimarestan mousavi
City
Zanjan
Province
Zanjan
Postal code
4513986961
Phone
+98 24 3313 0001
Email
nazlighamari@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nazli Ghamari
Position
Senior resident of obstetric and gynaecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gavazanh bimarestan mousavi
City
Zanjan
Province
Zanjan
Postal code
4513986961
Phone
+98 24 3313 0001
Email
nazlighamari@zums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Loading...