The aim of this study is evaluation the ART outcome in women with PCOS. Whose are candidate for controlled ovarian stimulation for IVF with GnRH antagonist fixed or flexible protocols.
In the fixed GnRH antagonist protocol, gonadotropin stimulation with 150 IU of gonadotropins rFSH is initiated on day 3 of menstruation after discontinuation of OCPs. Then Cetrotide 0.25 mg daily s.c is administrated on day 6 of gonadotropin stimulation.
In the flexible GnRH antagonist protocol daily s.c administration of Cetrotide 0.25 mg is initiated when at least one follicle measuring 12 mm; is presented
.The starting dose of rFSH was 150 IU/day for all patients in both groups. Ultrasound monitoring continued until hCG administration. When three follicles reach a mean diameter of _17 mm, hCG
Is administered i.m.. 34–36 h after 10,000 IU hCG injection, transvaginal ultrasound-guided oocyte retrieval is performed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101135181N5
Registration date:2013-02-25, 1391/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-25, 1391/12/07
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences -Vice-chancellor for research -Tehran University of Medical Science
r
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fixed versus flexible GnRH antagonist protocols outcomes in controlled ovarian stimulation for IVF/ICSI in polycystic ovary syndrome.
Public title
Evaluation of fixed versus flexible GnRH antagonist protocols outcomes in controlled ovarian stimulation in polycystic ovary syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : infertile patients with poly cystic ovary syndrome;20-40 years old
Body mass index BMI 20-30 kg/m2
Exclusion criteria: endometriosis;ovarian cysts; pelvic neoplasia of the uterine and ovarian ; endocrine disorders (disorders of tyroid , prolactin); male factor infertility; blocked fallopian tubes in HSG, FSH levels on the 3th day of menestration >12miu/ml, previous OHSS; history of RIF (RECURRENT IMPLANTATION FAILURE)
the presence of gestational sac with fetal heart beat detectionat 6–7 weeks of gestation
Secondary outcomes
1
Description
dose of cetrotide
Timepoint
at the end of controlled ovarian stimulation period
Method of measurement
dose of administration of Cetrotide
2
Description
duration of administration of Cetrotide
Timepoint
at the end of controlled ovarian stimulation period
Method of measurement
days of administration of Cetrotide
3
Description
Ongoing pregnancy
Timepoint
the presence of gestational sac with fetal heart beat detection at 12 w of gestation
Method of measurement
the presence of gestational sac with fetal heart beat detection at 12 w of gestation
4
Description
duration of administration of rFSH
Timepoint
at the end of controlled ovarian stimulation period
Method of measurement
days of administration of rFSH
5
Description
dose of rFSH
Timepoint
at the end of controlled ovarian stimulation period
Method of measurement
dose of administration of rFSH
6
Description
hospitalization rate due to OHSS
Timepoint
at the controlled ovarian stimulation period -UNTIL 4 weeks after pregnancy
Method of measurement
days of hospitalization due to OHSS
Intervention groups
1
Description
Intervention group 1 : In the fixed group , on day 3 of menstruation, gonadotropin stimulation with 150 IU subcutaneous of rFSH is initiated, Then Cetrotide 0.25 mg daily subcutaneous is administrated on day 6 of gonadotropin stimulation. When diameter of at least 3 follicles is more than 17 mm, HCG 1000IU intra muscular is administrated . Then 34-36 hours ovarian puncture under general anesthesia will done .
Category
Treatment - Drugs
2
Description
Group 2( flexible ):Third day of menstrual bleeding, gonadotropin 150IU rFSH (Gonalf ) is began daily subcutaneously.
Then if there is a follicle ≥ 12 mm ,Cetrotide 0.25 mg is administered subcutaneously. HCG 1000IU intra muscular is administrated . Then 34-36 hours ovarian puncture under general anesthesia will done . In both groups ,rFSH gonadotropin is adjusted based on monitoring ultrasonographic and Cetroid injection until HCG injection will continue.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr reproductive health research center of Tehran -infertility clinic
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical SciencesVice-chancellor of research,
Full name of responsible person
MIS Azvan
Street address
Vice-chancellor of research of Tehran University of Medical Sciences-5th floor-Ghods Ave-Keshavarz Blvd.
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 SciencesVice-chancellor of research,
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
Vali-e-Asr reproductive HealthnResearch center
Full name of responsible person
Tahereh Behroozi lak
Position
Associate professor
Other areas of specialty/work
Street address
,Imamkhomeini Hospital,Val-asr Hospital,Vali-e-Asr reproductive HealthnResearch center
City
Tehran
Postal code
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
t.behrooz2@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vali-e-Asr reproductive health research center
Full name of responsible person
DrBtool Hosein Rashidi
Position
Assistant professor
Other areas of specialty/work
Street address
-Keshavarz Blvd. Tehran Emam KHomeini complex hospitaVali-e-Asr reproductive health research centerl
City
Tehran
Postal code
Phone
+98 21 6119 2449
Fax
+98 21 6658 1658
Email
bhrashidi@tums.ac.ir t.behrooz2@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vali-e-Asr reproductive health research center
Full name of responsible person
Dr.Tahereh Behroozi Lak
Position
assistant
Other areas of specialty/work
Street address
Vali-e-Asr reproductive health research center-Keshavarz Blvd. Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2449
Fax
Email
t.behrooz2@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)