The effect of low dose hCG with GnRH agonist in decreasing rate of ovarian hyper stimulation syndrome in IVF cycles in Omid clinic and Shariati hospital in Teharn in 1394 and 1395.
The purpose of study is evaluation of the effect of low dose hCG with GnRH agonist in decreasing rate of ovarian hyper stimulation syndrome (OHSS) in IVF cycles. This study is a single blind randomized clinical trial which is done on infertile women who are referred for IVF in Omid clinic and Shariati hospital in 1394 and 1395. Eighty infertile women are enrolled in two groups, 40 women in interventional group and 40 women in control group. Inclusion criteria are infertile women with following conditions: 18-39 year old; Normal FSH level; AMH>3.5 ng/ml; Poly cystic ovary (AFC>24); Previous ovarian hyper stimulation syndrome; In the day of oocyte retrieval the number of follicles bigger than 18mm>16 or Estradiol>4000 pg/ml. Maternal age greater than 40 year or hypothalamic dysfunction is excluded from the study. Interventional group receives GnRH agonist and after 36 hours low dose hCG is injected. Control group receives GnRH agonist and low dose hCG at the same time. After 36 hours, in both groups oocyte retrieval is performed guided by transvaginal sonography. Symptoms and signs of OHSS are evaluated during 2 weeks after oocyte retrieval. Pregnancy test is checked 2 weeks after embryonal transfer. Main outcome of this study is symptoms and signs of OHSS (Abdominal pain, Oliguria, Weight gaining, Nausea and Vomiting) which are evaluated during 2 weeks after oocyte retrieval.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031427045N1
Registration date:2016-05-09, 1395/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-09, 1395/02/20
Registrant information
Name
Venus Chegini
Name of organization / entity
Tehran University of Medical Sciences, Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 8810
Email address
aleyasin@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2015-12-28, 1394/10/07
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose hCG with GnRH agonist in decreasing rate of ovarian hyper stimulation syndrome in IVF cycles in Omid clinic and Shariati hospital in Teharn in 1394 and 1395.
Public title
The effect of low dose hCG with GnRH agonist in decreasing rate of ovarian hyper stimulation syndrome in IVF cycles.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Infertile women with following conditions: 18-39 year old; Normal FSH level; AMH>3.5 ng/ml; Poly cystic ovary (AFC>24); Previous ovarian hyper stimulation syndrome; in the day of oocyte retrieval the number of follicles bigger than 18mm>16 or Estradiol>4000 pg/ml
Exclusion criteria: Maternal age>40 year; Hypothalamic dysfunction.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethic Committee of Tehran University of Medical Sciences
Street address
Ethic Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran
City
Tehran
Postal code
1417653761
Approval date
2015-12-28, 1394/10/07
Ethics committee reference number
IR.TUMS.REC.1394.1508
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N98.1
ICD-10 code description
Complications associated with artificial fertilization, Hyperstimulation of ovaries
Primary outcomes
1
Description
ovarian hyper stimulation syndrome
Timepoint
2 weeks after embryonal transfer
Method of measurement
Transvaginal ultrasonography and examination
Secondary outcomes
1
Description
Chemical Pregnancy
Timepoint
14 days after embryonal transfer
Method of measurement
βhCG titration
2
Description
Implantation rate
Timepoint
4 weeks after embryonal transfer
Method of measurement
Observationl of gestational sac in transvaginal sonography
3
Description
Clinical pregnancy rate
Timepoint
2 weeks after positive pregnancy test
Method of measurement
Observation of gestational sac in transvaginal sonography
Intervention groups
1
Description
Interventional group receives 150 IU FSH daily from the second day of menses. When the 14 mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix) 0.25mg subcutaneously daily is added. After the observation of at least two 18mm follicles, GnRH agonist (Bucerellin 0.5 mg) is injected. After 36 hours, low dose hCG is injected and oocyte retrieve is performed under general anesthesia. Three days after fertilization, transcervical embryo transfer will be carried out. Symptoms and signs of OHSS (Abdominal pain, Oliguria, Weight gaining, Nausea and Vomiting) are evaluated during 2 weeks after oocyte retrieval. Pregnancy test is checked 14 days after embryonal transfer. 2 weeks after positive test, by the aid of transvaginal ultrasound the pregnancy sac and fetal heart are detected.
Category
Prevention
2
Description
Control group, receives 150 IU FSH daily from the second day of menses. When the 14 mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix) 0.25mg subcutaneously daily is added. After the observation of at least two 18mm follicles, GnRH agonist (Bucerellin 0.5 mg) and low dose hCG are injected. After 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization, transcervical embryo transfer will be carried out. Symptoms and signs of OHSS (Abdominal pain, Oliguria, Weight gaining, Nausea and Vomiting) are evaluated during 2 weeks after oocyte retrieval. Pregnancy test is checked 14 days after embryonal transfer. 2 weeks after positive test, by the aid of transvaginal ultrasound the pregnancy sac and fetal heart are detected.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid clinic and Shariati Hospital
Full name of responsible person
Dr. Venus Chegini
Street address
Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masood Younesian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences, Shariati Hospital
Full name of responsible person
Dr Venus Chegini
Position
Obstetric and Gynecologic Resident
Other areas of specialty/work
Street address
Shariati Hospital, North Karegar Street, Tehran, Obstetric and Gynecologic Unit
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
Email
venus_chegini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Aghahosseini
Position
Professor
Other areas of specialty/work
Street address
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
Email
aghahosseini@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences, Shariati Hospital
Full name of responsible person
Dr Venus Chegini
Position
Obstetric and Gynecologic Resident
Other areas of specialty/work
Street address
Shariati Hospital, North Karegar Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8800 8810
Fax
Email
venus_chegini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)