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Administration of bolus follicle stimulating hormone (FSH) with trigger dose human chorionic gonadotropin (hCG) in prevention of ovarian hyperstimulation syndrom (OHSS)

Protocol summary

Summary
this study is designed for evaluate the efficacy of FSH in preventing OHSS, 70 women recruite for this study are : 25 to 40 years old,under a long agonist GnRH suppression IVF protocol at infertility department of Shariati hospital,with >20 follicles in ART cycles ultrasonography, They prospectively randomize to two strategy groups (gp1&2) for the prevention of OHSS. In gp1 (35 patient) cases give 450 IU of FSH at the time of the hCG trigger. For gp2 (35 patients) only hCG trigger administer. Patients will follow at days 3, 10 post oocyte retrieval. Symptoms of OHSS (lower abdominal discomfort, abdominal distension, nausea and/or vomiting, rapid weight gain, dyspnea,and progressive oliguria), volumes of ovaries and ascites will observe. Patients will divide to 3 groups, mild/moderate/severe OHSS. Number of metaphase II oocytes, fertilization rate and clinical pregnancy will check.

General information

Acronym
FSH,hCG,OHSS
IRCT registration information
IRCT registration number: IRCT201407206063N3
Registration date: 2014-08-11, 1393/05/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-11, 1393/05/20
Registrant information
Name
Fateme Sarvi
Name of organization / entity
Shariati Hospital, Fertility center
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
fsarvi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Science
Expected recruitment start date
2014-07-30, 1393/05/08
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Administration of bolus follicle stimulating hormone (FSH) with trigger dose human chorionic gonadotropin (hCG) in prevention of ovarian hyperstimulation syndrom (OHSS)
Public title
FSH effect in OHSS prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:25 to 40 years old woman;under a long agonist suppression IVF protocol at infertility department of Shariati hospital; with >20 follicles in ART cycles ultrasonography, exclusion criteria:دno trend to contribution.
Age
From 25 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Tehran University of Medical Science and Health Services
Street address
Ghods St, Keshavarz Blvd
City
Tehran
Postal code
1417614411
Approval date
2014-07-06, 1393/04/15
Ethics committee reference number
93/د/854/130

Health conditions studied

1

Description of health condition studied
OHSS
ICD-10 code
N98.1
ICD-10 code description
Hyperstimulation of ovaries

Primary outcomes

1

Description
OHSS severity
Timepoint
days 3,10 after ovarian puncture
Method of measurement
sign,symptom and vaginal sonography

2

Description
clinical pregnancy rate
Timepoint
2 weeks after transfer
Method of measurement
vaginal sonography

Secondary outcomes

1

Description
number of oocyte collected
Timepoint
day of puncture
Method of measurement
counting

2

Description
number of M2 oocyte
Timepoint
day of puncture
Method of measurement
counting

Intervention groups

1

Description
cases give one dose of 450 IU of FSH sub cutaneous at the time of the hCG trigger. Patients will followed at days 3, 10 post oocyte retrieval. Symptoms of OHSS (lower abdominal discomfort, abdominal distension, nausea and/or vomiting, rapid weight gain, dyspnea,and progressive oliguria), volumes of ovaries and ascites will observe .
Category
Treatment - Drugs

2

Description
For control group hCG trigger administer as usual method , then they will followe at days 3, 10 post oocyte retrieval. Symptoms of OHSS (lower abdominal discomfort, abdominal distension, nausea and/or vomiting, rapid weight gain, dyspnea,and progressive oliguria), volumes of ovaries and ascites will observe .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital, Infertility Centre
Full name of responsible person
Leila Arshadi
Street address
Amirabad Ave, Gisha Brd
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science and Health Service
Full name of responsible person
Leila Arshadi
Street address
Amirabad Ave, Gisha Brd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science and Health Service
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
Tehran University of Medical Science and Health Service, Shariati Hospital
Full name of responsible person
Leila Arshadi
Position
OB/GYN Resident
Other areas of specialty/work
Street address
Amirabad Ave, Gisha Brd
City
Tehran
Postal code
Phone
+98 21 8490 2407
Fax
Email
leilaarshadi@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science and Health Service, Shariati Hospital
Full name of responsible person
Leila Arshadi
Position
OB/GYN resident
Other areas of specialty/work
Street address
Amirabad Ave, Gisha Brd
City
Tehran
Postal code
Phone
+98 21 8490 2407
Fax
Email
leilaarshadi@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science and Health Service, Shariati Hospital
Full name of responsible person
Leila Arshadi
Position
OB/GYN Resident
Other areas of specialty/work
Street address
Amirabad Ave, Gisha Brd, Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2407
Fax
Email
leilaarshadi@ymail.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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