This study was designed to evaluate the effectiveness of GnRh agonist for luteal support on improvement of intracytoplasmic sperm injection (ICSI) cycles. This clinical trial is performed in Infertility and IVF ward, Taleghani hospital. 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 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101729027N2
Registration date:2016-10-24, 1395/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-24, 1395/08/03
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
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
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 intracytoplasmic sperm injection cycles: clinical trial
Public title
Effects of GnRH agonist for luteal support on improvement of intracytoplasmic sperm injection cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20-38; 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
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Postal code
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
IR.SBMU.MSP.REC.1395.65
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 days after ICSI
Category
Treatment - Drugs
2
Description
Control group: Subcutaneous injection of placebo 6 days after ICSI
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and IVF ward of Talghani hospital
Full name of responsible person
Leila Nazari
Street address
Yaman St, Velenjak, Chamran highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of 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
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 of Shahid Beheshti University of Medical Sciences