This study was designed to evaluate the effectiveness of GnRh agonist for luteal support on improvement of intracytoplasmic sperm injection (ICSI) cycles.
Design
240 infertile patients who candidate ICSI with normal ovarian response are recruited into the study in two groups according to randomization method. Subcutaneous injection of 0.1 mg Triptorelin or placebo is performed 6 and 9 days after ICSI. Luteal support is performed for all participants as a same protocol (Vaginal Cyclogest 400 mg twice/day). Chemical and clinical pregnancy rate and abortion rate will be analyzed.
Settings and conduct
This clinical trial is performed in Infertility and IVF ward, Taleghani hospital
Participants/Inclusion and exclusion criteria
Age between 20-38 years old; body mass index (BMI) between 20-30; fresh embryo transfer cycles; 3rd menstrual day serum FSH below 10; absence of low ovarian response
Intervention groups
Intervention group: subcutaneous injection of Triptorelin (0.1 mg) 6 days after ICSI.
Control group: subcutaneous injection of placebo 6 days after ICSI.
Main outcome variables
Chemical pregnancy; clinical pregnancy; ongoing pregnancy; abortion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160722029027N6
Registration date:2018-09-20, 1397/06/29
Registration timing:registered_while_recruiting
Last update:2018-09-20, 1397/06/29
Update count:0
Registration date
2018-09-20, 1397/06/29
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of GnRH agonist for luteal support on improvement of IVF/ICSI cycles
Public title
Effects of GnRH agonist for luteal support on improvement of IVF/ICSI cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-38 years old
Body mass index (BMI) between 20-30
Fresh embryo transfer cycles
3rd menstrual day serum FSH below 10
Absence of low ovarian response according Bologna Criteria
Exclusion criteria:
Unwillingness to continue
Absence of good quality embryo
Ovarian hyper stimulation (more than 18 mature follicle during ovarian stimulation)
Age
From 20 years old to 38 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was randomized . In this method, we use the numerical random number table to choose the numbers, for example, if the sample size is two digits. First, select a two-digit number completely randomly, for example by placing the pencil tip, and then go ahead and select two-digit numbers to get the required number.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is double-blind study, that the participants do not know which of the two control or test groups belong, and also the observers (researchers) do not know who the group is.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-01-26, 1396/11/06
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.994
Health conditions studied
1
Description of health condition studied
Noninflammatory disorders of female genital tract
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Transvaginal ultrasound
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
Serum BHCG
Secondary outcomes
1
Description
Ongoing pregnancy
Timepoint
10 weeks after embryo transfer
Method of measurement
Fetal heart beat in ultrasound
2
Description
Abortion
Timepoint
Before 20 weeks of pregnancy
Method of measurement
Fetal demise before 20 weeks of gestation
Intervention groups
1
Description
Intervention group: Subcutaneous injection of Triptorelin (0.1 mg) 6 and 9 days after ICSI
Category
Treatment - Drugs
2
Description
Control group: Subcutaneous injection of placebo(Normal saline) 6 and 9 days after ICS
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF Infertility and IVF ward of Talghani hospital
Full name of responsible person
Leila Nazari
Street address
Yaman St., Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
nazari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st., Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
nazari@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?