Protocol summary

Summary
overall objective of the best luteal phase support upon pregnancy outcome in frozen –thawed embryo transfer cycle dedicated objectives : 1-survey effect of didrogesteron in comparison by cyclogest upon clinical pregnancy rate in frozen thawed embryo transfer cycle 2- survey effect of didrogesteron in comparison by cyclogest upon ongoing pregnancy rate in frozen thawed embryo transfer cycle 3- survey effect of didrogesteron in comparison by cyclogest upon abortion rate in frozen –thawed embryo transfer cycle 4- survey effect of didrogesteron with GnRH-a in comparison by cyclogest upon clinical pregnancy rate in frozen –thawed embryo transfer cycle 5- survey effect of didrogesteron with GnRH-a in comparison by cyclogest upon ongoing pregnancy rate in frozen –thawed embryo transfer cycle 6-survey effect of didrogesteron with GnRH-a in comparison by cyclogest upon abortion rate in frozen –thawed embryo transfer cycle 7- survey effect of didrogesteron with HCG in comparison by cyclogest upon clinical pregnancy rate in frozen –thawed embryo transfer cycle 8-survey effect of didrogesteron with HCG in comparison by cyclogest upon ongoing pregnancy rate in frozen –thawed embryo transfer cycle 9- survey effect of didrogesteron with HCG in comparison by cyclogest upon abortion rate in frozen thawed embryo transfer cycle inclusion criteria: 1-unexplained infertility 2- tubal factor 3-mild male factor 4-POF 5-sub fertility in pco field 6-average age between 20-40 7-normal uterine cavity exclusion criteria: 1-women over 40 year 2-endometriosis stage III ،IV 3-Hydro salpinx 4- severe male factor 5-ab normal uterine cavity 6-failed embryo transfer cycle ≥3 methods: According to previous studies and consult with statistics 400 patients were entered to our study.patients who were scheduled for IVF in infertility clinic of mother and child hospital,and Dena hospital of Shiraz city were assessed for having inclusion criteria,patients that were 20-40 y with normal uterine cavity and special infertility cause were included and patients that had more than 40 y with abnormal uterine cavity and more or equal 3 unsuccessful embryo transfer cycle were excluded . After entrance to stimulation cycles ,in third day of past ovum pick up,embryos were assessed for quality and counts of blastomers.If number of blastomers were more than or equal 8 with fragmentation rate less than 20%,embryo was freezes as Top quality embryo with vitrification method in cleavage stage.The patients who had Top quality freeze embryo were admitted in next cycle for preparation endometrium. Estradiol was started from second day of menstrual cycle , progesterone ampule 100 mg/d for three days was prescribed after getting adequate endometrial thickness. Number of embryo for transfer was determined according to mother age. after taking testimonial form study,patients randomized and divided to four groups for receiving luteal phase support. - First group:patients who received cyclogest vaginal suppository 400 mg twice a day. - Second group: patients who received didrogesteron oral tablet 10 mg twice a day. - Third group: patients who received didrogesteron oral tablet 10mg twice a day in combination with 3 dose of Amp Dipherelin 0.1mg in days of embryo transfer,3 day,6 day . - Fourth group: patients who received didrogesteron oral tablet 10mg twice a day in combination with 3 dose of Amp HCG 1500u in days of embryo transfer,3 day,6 day - HCG Test was done 16 days after embryo transfer.if the test was positive ,trans vaginal ultra sound was done 6 week and 12 week later for determining clinical pregnancy rate and ongoing pregnancy rate.Meanwhile luteal phase support was continued till 12 week gestation. - Main outcome were consist of clinical pregnancy rate ,ongoing pregnancy rate, abortion rate that was recorded for 4 groups and after statistical analysis were compared for assessing best luteal phase support in frozen-thaw embryo transfer cycle.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014082510210N3
Registration date: 2015-02-14, 1393/11/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
Afsun Zarei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
zareia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Scienses
Expected recruitment start date
2014-12-16, 1393/09/25
Expected recruitment end date
2015-06-15, 1394/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
assessment of the best luteal phase support (comparison of four protocols) for patients undergoing frozen-thawed embryo transfer in artificial cycle.
Public title
Effect of four treatment protocols upon pregnancy outcome in frozen-thawed embryo transfer cycle.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: unexplained infertility ؛ tubal factor؛ mild male factor ؛ POF ؛ sub fertility in pco field ؛ average age between 20-40؛ normal uterine cavity exclusion criteria: women over 40 year؛ endometriosis stage III ،IV؛ Hydro salpinx ؛ severe male factor؛ ab normal uterine cavity ؛ failed embryo transfer cycle ≥3
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Science Researching، Shiraz Univercity of Medical Science
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Postal code
Approval date
2014-12-14, 1393/09/23
Ethics committee reference number
ct-p-9384-8114

Health conditions studied

1

Description of health condition studied
luteal phase
ICD-10 code
N94.8
ICD-10 code description
Other specified conditions associated with female genital organs and menstrual cycle

Primary outcomes

1

Description
Clinical pregnancy rate
Timepoint
6 week gestation
Method of measurement
vaginal sonogeraphy trans

Secondary outcomes

1

Description
ongoing pregnancy rate,Abortion rate
Timepoint
12 week gestation
Method of measurement
vaginal sonogeraphy trans

Intervention groups

1

Description
control group : received cyclogest vaginal suppository twice a day for luteal phase support
Category
Treatment - Drugs

2

Description
intervention group 1: patients who received didrogesteron oral tablet 10mg twice a day.
Category
Treatment - Drugs

3

Description
intervention group2: patients who received didrogesteron oral tablet 10mg twice a day in combination with 3 dose of Amp Dipherelin 0.1mg in days of embryo transfer,(3 day,6 day )
Category
Treatment - Drugs

4

Description
intervention group3: patients who received didrogesteron oral tablet 10mg twice a day in combination with 3 dose of Amp HCG 1500u in days of embryo transfer,(3 day,6 day)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother & Child hospital
Full name of responsible person
Parastoo soheil
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
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 of Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr parastoo soheil
Position
Fellowship of Obstetrics & GYN, Infertility
Other areas of specialty/work
Street address
Shiraz university of medical science ، zand street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
Parastoosoheil@yahoo.com s.kharati@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr afsoon zarei
Position
Professor of Obstetrics & GYN, Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
zareia@sums.ac.ir s.kharati@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Sara kharati
Position
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
+98 917 801 5165
Fax
Email
s.kharati@yahoo.com
Web page address

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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