Comparing IVF outcomes in GnRH antagonist protocol during early and late follicular phase and GnRH antagonist protocol(flexible) and long GnRH agonist protocol in patients with polycystic ovary syndrome .
In this study we compare the results of In Vitro Fertilization(IVF) in three groups of new protocol (GnRH antagonist administration in early and late follicular phase ) and GnRH antagonist protocol (flexible) and GnRH agonist long protocol in patients with poly cystic ovary syndrom(PCOS) . Therefore of the PCOS patients refere to Avicenna Infertility Center from 21/7/2013 until 22/10/2013 with IVF indication for their infertility, 50 patients will be randomized in each group (total 150 patients) and evaluated .PCOS patients will be selected based on Rotterdam criteria with age 20-38 years old and they are not in IVF failure group as our inclusion and exclusion criteria.In new protocol we prescribe GnRH antagonist on day1,2 Gonadotropine ovarian stimulation and then after atleast 2 follicles reach to 13-14 milimeter.Then IVF outcomes will be evaluated in three groups for clinical pregnancy rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120311653N1
Registration date:2013-07-16, 1392/04/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Sara Mokhtar
Name of organization / entity
Avicenna Infertility Treatment Center
Country
Iran (Islamic Republic of)
Phone
+98 21 23519
Email address
s.mokhtar@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Infertility Treatment Center
Expected recruitment start date
2013-07-21, 1392/04/30
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing IVF outcomes in GnRH antagonist protocol during early and late follicular phase and GnRH antagonist protocol(flexible) and long GnRH agonist protocol in patients with polycystic ovary syndrome .
Public title
Comparasion between several ovarian stimulation protocols for infertility treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PCOS patients based on Rotterdam criteria with IVF indication for their infertility ; Age 20-38 Y; Normal Sexual development and Normal puberty; Patients without cardiac and vascular -renal-hepatic disease ; FSH<12 in third day of menstrual cycle ; Normal TSH and Prolactin
Exclusion criteria: Hormon Therapy during recent 3 month ; ART failurs>2 ; recurrent abortion >=2 in first trimester ; Cervical and uterine anatomical abnormality ; ovarian cysts ; Hydrosalpinx
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Avicenna infertility treatment center
Street address
Avicenna Infertility Center, No 97, Yakhchal-Shariati junction, Shariati st, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-11-05, 1391/08/15
Ethics committee reference number
91/ص/15/2822
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrom
ICD-10 code
ٍE90
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
After intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Biochemical pregnancy
Timepoint
After intervention
Method of measurement
HCG
Intervention groups
1
Description
In GnRH antagonist group with early and late follicular phase:Cetrorelix0.25mg starts on day1,2 gonadotropin stimulation and when atleast 2 follicles reach 13-14 mm and continues until HCG administration.
Category
Treatment - Drugs
2
Description
In GnRH agonist (long protocol)group:superfact 0.5 mg starts from day21 prior menstrual cycle and 0.25 mg superfact with gonadotropin stimulation and continues until HCG administration.
Category
Treatment - Drugs
3
Description
In GnRH antagonist (flexible)protocol group: cetrorelix 0.25mg starts when atleast 2 follicules reach 13-14mmand continues until HCG administration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Infertility Treatment Center
Full name of responsible person
Dr Sara Mokhtar
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati st, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Infertility Treatment Center
Full name of responsible person
Dr Akhondi
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati st, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Infertility Treatment Center
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
Avicenna Infertility Treatment Center
Full name of responsible person
Sara Mokhtar
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati st, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2261 7930
Fax
Email
s.mokhtar@avicenna.ac.ir
Web page address
www.avicenna.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Avicenna Infertility Treatment Center
Full name of responsible person
Dr Afsane Mohammadzade
Position
Obstetrician & Gynecologist
Other areas of specialty/work
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati st, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 23519
Fax
Email
af85af@yahoo.com
Web page address
www.avicenna.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Avicenna Infertility Treatment Center
Full name of responsible person
Sara Mokhtar
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati st, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2261 7930
Fax
Email
smkhtr@yahoo.coms.mokhtar@avicenna.ac.ir
Web page address
www.avicenna.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)