1. Home
  2. Approved trials
  3. » فارسی

A Comparetive study of cyclogest and GNRH-A+ cyclogest effect on luteal phase support in cycles of frozen embryo transfer

Protocol summary

Summary
Goal: a comparative study of cyclogest and GNRH-A + cyclogest effect on luteal phase support in cycles of frozen embryo transfer Study is accidental single blind clinical study People under study:Infertile females that refer to madar and Koudak hospital in shiraz 1395 with including criteria: Un explain infertility,tubal factor,mild male factor,POF,PCO,age 20-40 y/o with normal uterine cavity Excluding criteria: Age> 40y/o,abnormal uterine cavity, stage 3&4 endometriosis,hydrosalpinx,sever male factor,unsuccess embryo transfer>2 cycle In this trial,240 women with infertility and IVF candidate again,divided in 2 equal 120 groups that include:consumers of cyclogest (800mg daily) and Dipherlin 0.1mg 3 dose in transfer time and 3&6 days after it with cyclogest(800mg daily) for luteal phase support groups. The frozen embryos from IVF are transferred to uterus and implantation rate,clinical pregnancy,ongoing pregnancy and abortion are compares.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020510210N7
Registration date: 2017-03-01, 1395/12/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-01, 1395/12/11
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 Sciences
Expected recruitment start date
2016-09-20, 1395/06/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparetive study of cyclogest and GNRH-A+ cyclogest effect on luteal phase support in cycles of frozen embryo transfer
Public title
Effect of two treatment protocols upon pregnancy outcome in IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Un explain infertility,tubal factor,mild male factor,POF,PCO,age 20-40 y/o with normal uterine cavity Exclusion criteria: Age> 40y/o,abnormal uterine cavity, stage 3&4 endometriosis,hydrosalpinx,sever male factor,unsuccess embryo transfer>2 cycle
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: 240
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Postal code
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.SUMS.MED.REC.1395.49

Health conditions studied

1

Description of health condition studied
Infertility and treatment methods
ICD-10 code
N97
ICD-10 code description
Female infertility

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
Trans vaginal sonogeraphy

Intervention groups

1

Description
Received cyclogest vaginal suppository twice a day for luteal phase support
Category
Treatment - Drugs

2

Description
patients who received GNRH-A + Cyclogest
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother & Child hospital
Full name of responsible person
Marzieh Eslami moghadadm
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. Marazieh Eslamimoghadam
Position
Rezedent of Obstetrics & GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences، Zand street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
marzieh.eslami@ymail.comhafez_perina@sums.ac.ir
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 3233 2365
Fax
Email
Zareia@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
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 3233 2365
Fax
Email
hafez_perina@sums.ac.ir
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
Loading...