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Comparison of oral progesterone with vaginal and subcutaneous progesterone for luteal phase support on pregnancy rate of infertile patients underwent intracytoplasmic sperm injection- Embryo transfer cycles

Protocol summary

Summary
Objective: To compare pregnancy rates resulting from oral Dydrogesterone with vaginal progesterone for luteal phase support in in vitro fertilization. Design: A randomized multicenter clinical trial. Setting and conduct and participants including major eligibility criteria: This study is done in infertility clinic of Taleghani and Mahdieh Hospital, martyr Beheshti University, Tehran, Iran from April 2014 until January 2015, 200 infertile patients that are in age range of 20 -45 years old and don’t have any anomaly in uterine cavity evaluation and don’t have any advanced endometriosis, dense pelvic adhesion,genital TB, previous intracytoplasmic sperm injection failures which thay are undergoing intra cytoplasmic sperm injection-Embryo transfer cycles are including in this study. Interventions: patients randomly have been divided into two groups or 40mg dydrogesterone (Tablet duphaston 10mg, The pharmaceutical company Abbot,Netherland) ) or vaginal suppositories progesterone (suppository, 400mg , Actoverco , Great Britain) that started on oocytes recoverys day and This medication will be continued until 12 weeks of pregnancy. Main outcome measures: Clinical pregnancy rate. second outcomes measures: chemical and ongoing pregnancy and miscarriage rates, patient acceptance

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014071212494N2
Registration date: 2014-12-08, 1393/09/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-08, 1393/09/17
Registrant information
Name
Nasrin Saharkhiz
Name of organization / entity
Infertility & Reproductive Health Research Centre of SHahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
saharkhiz.n@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Science
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral progesterone with vaginal and subcutaneous progesterone for luteal phase support on pregnancy rate of infertile patients underwent intracytoplasmic sperm injection- Embryo transfer cycles
Public title
Effect of progesterone on pregnancy rate of assisted reproduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; Women at age 20-45 yearsold: Undervent intracytoplasmic sperm injection-Embryo trnsfer(ICSI-ET)(Fresh cycle): Have normal endometrial thickness(7-12) on embryo transfer day; Don't have any observational endometrial pathology enter in to the study. Exclusion criteria; Advanced endometriosis; Dense pelvic adhesion; Genital TB; Previous intracytoplasmic sperm injection( ICSI) cycle failures.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Infertility & Reproductive Health Research Center Ethics committee of Shahid Beheshti University of
Street address
3rd floor, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
308/794

Health conditions studied

1

Description of health condition studied
Other complications associated with artificial fertilization
ICD-10 code
N98
ICD-10 code description
Noninflammatory disorders of female genital tract

Primary outcomes

1

Description
Clinical pregnancy rate
Timepoint
Five weeks after start of intervention
Method of measurement
Transvaginal ultrasonography

Secondary outcomes

1

Description
Patients acceptance
Timepoint
Untill 12 weeks
Method of measurement
Questionare

2

Description
Miscariage rate
Timepoint
Until 24 weeks after start of intervention
Method of measurement
History, Physical exam, Ultrasonography

3

Description
Chemical pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
Labratory kit

Intervention groups

1

Description
Intervention: Duphaston(Oral Didrogesterone 10mg, Abbott, Netherland) 20mg , Twice daily until 12 weeks.
Category
Treatment - Drugs

2

Description
Intervention: Subcutaneous progesterone (Prolutex, 25mg, IBSA company, Switzerland) daily injection until 12 weeks
Category
Treatment - Drugs

3

Description
Control: Vaginal suppository cyclogest,(A kind of vaginal progesterone, 400 mg, actover company,Britain)400mg twice daily until 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility & Reproductive Health Research Center Shahid Beheshti University of Medical Science
Full name of responsible person
Marzieh Zamanian
Street address
Taleghani hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Science
Full name of responsible person
Zahra Sadeghzade
Street address
Taleghani hospital, IVF ward, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Grant name
معاونت پژوهشی دانشگاه علوم پزشکی شهیدبهشتی
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Shafayab Gostar company
Full name of responsible person
Elham Sahafi
Street address
275 plaque, after Modarres bridge, Beheshti avenue
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shafayab Gostar company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Nasrin Saharkhiz
Position
Assistant professor of gynecology group
Other areas of specialty/work
Street address
Taleghani Hospital, IVF ward, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
saharkhiz1377@yahoo.com; www.irhrc.sbmu.ac.ir
Web page address
irhrc.sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Nasrin Saharkhiz
Position
Assistant professor of gynecology group
Other areas of specialty/work
Street address
IVF ward, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
saharkhiz1377@yahoo.com; www.irhrc.sbmu.ac.ir
Web page address
irhrc.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Infertility & Reproductive Health Research Centre - Shahid Beheshti of Medical Science
Full name of responsible person
Nasrin Saharkhiz
Position
Assistant professor of gynecology group
Other areas of specialty/work
Street address
IVF ward, Taleghani Hospital, Velenjak, Shahid Chamran highway, Tehran
City
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
saharkhiz1377@yahoo.com; www.irhrc.sbmu.ac.ir
Web page address
irhrc.sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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