The aim of the current study is evaluation of pregnancy rate in patients at risk for Ovarian Hyper Stimulation Syndrome (OHSS) who will be triggered with Gonadotropin-releasing hormone (GnRHa) in antagonist cycle. In this multi-center study, 280 women with high OHSS risk will be selected and divided randomly into two groups on the day of oocyte retrieval. There is no blindness in the study. The difference between groups is fresh embryo transfer in current cycle or embryo freezing and transfer of frozen –thawed embryos in the next cycle. At first, ovarian stimulation will be performed using antagonist protocol with administration of 150-200 IU gonadotropin. Patients who have14 to 25 follicles with the diameter more than 12 mm on the day of trigger and Body Mass Index (BMI) between 18-35 will be selected and triggered with GnRHa and will be divided to two groups randomly at the same day. In one group all embryos will be freezed and in another group two fresh embryos will be transferred. Chemical and clinical pregnancy rate will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092224512N4
Registration date:2016-10-03, 1395/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-10-03, 1395/07/12
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 358247085
Email address
abbas-aflatoonian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Shahid Sadoughi Univesity of Medical Science
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Fresh and Frozen Embryo Transfer in GnRH Agonist Triggered patients: A Multicenter Study
Public title
Pregnancy outcome in Fresh versus Freeze embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
age between 20-40; hyper responded patients; 14-25 follicles ≥ 12 mm on day of trigger; BMI >18 and <35 kg/m2
Exclusion Criteria:
Patients with <14 follicles and > 25 ≥ 12 mm on day of trigger; Previous OHSS; endocrine disorders
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Street address
Bouali Ave, Safayieh
City
Yazd
Postal code
Approval date
2013-12-09, 1392/09/18
Ethics committee reference number
255
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancy sterility, female NOS
Primary outcomes
1
Description
Chemical pregnancy rate
Timepoint
14 days after embryo transfer
Method of measurement
Beta-hCG using lab kit
Secondary outcomes
1
Description
clinical pregnancy rate
Timepoint
7 weeks after embryo transfer
Method of measurement
fetal heart rate in ultra sonography
Intervention groups
1
Description
Intervention group: Freeze of all embryos according to embryo freezing standard protocol at the same cycle.
Thaw all the embryos according to embryo thawing standard protocol and embryo transfer at the next cycle
Category
Treatment - Other
2
Description
Control group: Transfer of 2 fresh embryos at the same cycle Luteal phase support using oral Estradiol Valerat at the dose of 4 mg per day and progesterone (Cyclogest 400 mg) twice daily until observation of fetal heart activity
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Nasim Tabibnejad
Street address
Bouali Ave, Safayieh
City
Yazd
2
Recruitment center
Name of recruitment center
Madar Hospital
Full name of responsible person
Abbas Aflatoonian
Street address
Mahdieh Square
City
Yazd
3
Recruitment center
Name of recruitment center
Novin Infertility Center
Full name of responsible person
Mahnaz Mansouri
Street address
8th Kowsar Street, Kowsar BLVD
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amirhooshang Mehrparvar
Street address
Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Shahid Sadoughi 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
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Nasim Tabibnejad
Position
PhD student
Other areas of specialty/work
Street address
Bouali Ave, Safayieh
City
Yazd
Postal code
Phone
+98 35 3824 8121
Fax
Email
nasimtabibnejad@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Abbas aflatoonian
Position
Gynecologist
Other areas of specialty/work
Street address
Bouali Ave, Safayieh
City
Yazd
Postal code
Phone
+98 35 3824 8121
Fax
Email
abbas-aflatoonian@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences
Full name of responsible person
Nasim Tabibnejad
Position
PhD student
Other areas of specialty/work
Street address
Bouali Ave, Safayieh
City
Yazd
Postal code
8916816559
Phone
+98 35 3824 8121
Fax
+98 99683538247087
Email
nasimtabibnejad@ssu.ac.ir
Web page address
www.yazd-rsi.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)