Ovarian hyper stimulation syndrome (OHSS) is one of the
Major problems of ovarian stimulation during cycles of the patient's polycystic ovarian syndrome (PCOS) that treatment of IVF/ ICSI. In recent years, there have been reports that the incidence of OHSS is lower of the GnRH antagonists than of the GnRH agonists. GnRH antagonists may be useful for the PCOS patients. Yet, few studies have been published to compare the GnRH antagonists than of the GnRH agonists in PCOS patients. The purpose of this study was to compare GnRH antagonists and agonist in patients IVF/ICSI.
120 PCOS infertile women were enrolled in the study of Fatemeh Zahra Infertility Center. Inclusion criteria for this study included: (1) meeting of 2003 Rotterdam PCOS criteria ovulation…) and exclusion criteria (More than two abortions…). Patients are divided randomly into two groups. The women, who were in the group which received GnRH agonists, started one LD tablet daily from the second or third day of the cycle for a period of 14-21 days. In the day 21, they had injection cycle of 500mg GnRH agonists subcutaneously.
Antagonist group, ovulation starts with Gonal F injection from day 2 - 3 periods. A drug starts in women less than 30 years with 150 units and in women more than 30 years with 225 units. βHCG was tested in volunteers following 14 days after embryo transfer to the uterus. Individuals with positive βHCG test underwent fetal ultrasound at sixth to seventh weeks of gestation. Preimery results are including a positive pregnancy test, and secondary outcomes included duration of ovarian stimulation, number of medications, and the cost done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402041760N30
Registration date:2014-03-03, 1392/12/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-03, 1392/12/12
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2013-05-15, 1392/02/25
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of GnRH agonists and antagonists the outcome IVF/ICSI in women with polycystic ovary syndrome
Public title
Comparison of GnRH agonists and antagonists the outcome IVF/ICSI in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PCOs; having two of the three diagnostic criteria Rotterdam 2003(Irregular menstruation oligomenorrhea, amenorrhea and irregular bleeding); hyperandrogenism(Hirsutism, severe acne, hair loss); obesity; polycystic ovaries on ultrasound to rule out specific diseases such as disorders of the hypothalamus, pituitary or other causes hyperandrogenism ; age ≤ 35 years; FSH <12 mlu / ml on days 2-3 of the cycle
Exclusion criteria: history of more than two abortions;
in laparoscopic uterine anomaly, hysteroscopy & hysterosonography; ovarian cysts.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Ganjafroz Avenue, Babol University of Medical sciences
City
Babol
Postal code
Approval date
2013-05-14, 1392/02/24
Ethics committee reference number
2458/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Pregnancy
Timepoint
7-6 weeks to see the gestational sac
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Duration of ovarian stimulation
Timepoint
Duration of drug use
Method of measurement
Clinical
2
Description
Number of drugs
Timepoint
Duration of treatment
Method of measurement
clinical
3
Description
The cost
Timepoint
Time to confirm pregnancy
Method of measurement
Amount spent
Intervention groups
1
Description
Intervention Groups:
Agonist group GNRH, starting the cycle period of 2-3 days, 14-21 days, take one tablet daily for 21 days and the LD cycle Busereline 500mg Super artifact construction company (Aventis) will subcutaneously. After down regulation, stimulation with HMG or Gonal F Manufacturing Co. (IBSA, MARCK) begin until at least two follicles with a diameter of 18 mm will continue.
Category
Treatment - Drugs
2
Description
Control Groups:
Aldo Group ovulation period of 2-3 days with Gonal F starts in people younger than 30 years with 2 injections (150 units) and in women older than 30 years with 3 injections (225 units) starts. When the follicle diameter reached 10 mm,Serum E2> 600pg/ml, the daily Cetrorelix 0.25mg (manufactured by MERCK) started and will continue until the day of HCG injection subcutaneously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Naghmeh Noorani
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganjafroz Avenue, Babol University of Medical Sciences, Vice Chancellor for Research and Technology
City
Babol
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 and Technology, Babol 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
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Marmar Firoozpour Bandepei
Position
Midwifery Expert
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center,After Old Road Amol - Babol, Mohammad Hassan Khan Bridge,
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
farazmarmar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Infertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Mahtab Zeinalzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Infertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
zeinalmahtab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Other areas of specialty/work
Street address
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
Ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)