Objectives: Comparing effects of GnRH agonist versus hCG in final oocyte maturation in antagonist protocol of IVF cycle. Design: In this research a comparison among abovementioned approaches for triggering of final oocyte maturation is performed based on following criteria: (1) quality and number of retrieved oocytes (2) number and quality of embryos obtained (3) clinical and ongoing pregnancy rate (4) the risk of OHSS . Setting and Conduct, Inclusion and Exclusion Criteria: Candidate women for IVF with ages lower than 39 who will refer to private infertility clinic of Madar-O-Koodak hospital affiliated to Shiraz University of Medical sciences will be enrolled. The patients with Ovulatory factor infertility, Endometriosis and uterine anomalies will be excluded from study population. The remaining patients will be randomly allocated in two groups using random table of numbers. Interventions: In control group named as HCG group will receive HCG for mid-cycle triggering of final oocyte maturation as a standard IVF protocol. In intervention group the GnRH agonist will be used for mid-cycle triggering of final oocyte maturation. Main outcome measures: clinical pregnancy, hormonal assay, rate of OHSS, Number and quality of embryos obtained
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060222541N1
Registration date:2016-06-24, 1395/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-24, 1395/04/04
Registrant information
Name
Leila Sarikhani
Name of organization / entity
Shiraz Univesity of Medical School
Country
Iran (Islamic Republic of)
Phone
+98 71 3229 8396
Email address
dr.l.sarikhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Zand street , Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-26, 1391/12/08
Expected recruitment end date
2014-09-24, 1393/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A prospective randomized clinical trial on mid-cycle triggering of final oocyte maturation using GnRH versus HCG in Antagonist protocol
Public title
Comparing hormone profile and outcomes of ovulation triggering with GnRH and HGC in IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients who are candidate for IVF/ICSI( Male factor infertility, unexplained infertility, tubal factor infertility), Age below 39 years old, BMI: 18-29, Regular menstrual cycles.Agreement of patient to enrol the research
Exclusion criteria: Ovulatory factor infertility, Endometriosis, Uterine anomalies, Age above 39 years old, Non-agreement of patient to enrol the research
Age
From 24 years old to 36 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
232
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomisation will be implemented using table of random numbers.
Secondary Ids
1
Registry name
Shiraz University of Medical Sciences
Secondary trial Id
90-01-01-3979
Registration date
2012-09-10, 1391/06/20
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Science
Street address
Shiraz University of Medical Science , Zand street
City
Shiraz
Postal code
Approval date
2013-02-21, 1391/12/03
Ethics committee reference number
CT-P-91-3979
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Number and Quality of oocytes retrieved in each IVF cycle
Timepoint
on day of ovum pick up
Method of measurement
measuring number and quality of oocytes on the day of pick up by pathologist in lab under microscope and scoring.
2
Description
Progesterone level
Timepoint
on the day of injection HCG or GnRH agonist(Final Triggering) and rechecked 7 and 14 days after that
Method of measurement
Serum Level, Lab test
3
Description
Number and Quality of embryos transferred in IVF cycle
Timepoint
on day of embryo transfer
Method of measurement
measuring number and quality of embryos by pathologist in lab under microscope and grading.
4
Description
Comparing FSH, LH, Estradiol and HCG in both groups
Timepoint
on days 2 and 6 of menstrual cycle, final oocyte triggering, oocyte retrieval, 7 and 14 days after that oocyte retrieved
Method of measurement
Serum Level, Lab test
Secondary outcomes
1
Description
Rate of ovarian hyperstimulation syndrome (OHSS)
Timepoint
From day of HCG or GnRH agonist injection up to 2 weeks later
Method of measurement
Clinical management of symptoms, Sonography
2
Description
Clinical Pregnancy
Timepoint
16 days after triggering if menstruation was absent
Method of measurement
Serum BHCG and TVS
Intervention groups
1
Description
Intervention group: In intervention group the patient will receive GnRh agonist (Decapeptyl; Ferring, The Netherlands), 0.2 mg sc for triggering final oocyte maturation
Category
Treatment - Drugs
2
Description
Control group: In control group the patients will receive HCG 10000 IU sc (Institute Biochimique SA (IBSA), The Switzerland) for triggering final oocyte maturation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madar-Koodak Hospital
Full name of responsible person
Dr. Leila Sarikhani
Street address
Entrance of Gulshan Town, Quran Gate
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Shiraz 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
OB. & GYN Department, Shiraz Medical School
Full name of responsible person
Dr. leila Sarikhani
Position
Resident of OB. & GYN
Other areas of specialty/work
Street address
OB. & GYN. Office, Shahid Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3229 8396
Fax
Email
sarikhani_l@sums.ac.ir; dr.l.sarikhani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
OB. & GYN. Department, Shiraz Medical School
Full name of responsible person
Dr. Ebrahim Parsanezhad
Position
Head of OB. & GYN. Department, Proffesor
Other areas of specialty/work
Street address
OB. & GYN. Department, Shahid Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
parsame@rogers.ca; obgynward@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
OB. & GYN. Department, Shiraz Medical School
Full name of responsible person
Dr. Leila Sarikhani
Position
Resident of OB. & GYN.
Other areas of specialty/work
Street address
OB. & GYN. Office, Shahid Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3229 8396
Fax
Email
sarikhani_l@sums.ac.ir; dr.l.sarikhani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)