Protocol summary

Study aim
comparision between administration of FSH plus HCG verusus HCG alone for triggering, in the results of ICSI
Design
Clinical trials with community based and pragmatic control group, with parallel groups,one blind, randomized.
Settings and conduct
This study was conducted as a randomized one blind clinical trial.Normoresponder women who are referred to the avicenna Infertility Center, are randomly divided into two groups of 40, between the end of 1997 and the beginning of 1998 who are candidates for ICSI cycles. . Starting ultrasound in the case of a thin endometrium and lack of vision of the ovarian follicle larger than 10 millimeters of the antagonist cycle begins. The initial dose of gonadotrophin is based on age, weight, ovarian reserve and previous response to COH, and ultrasound and the visit are performed 5 days later, and then every 3-2 days. Dosage adjustment is based on follicular growth. The drugs used to stimulate the gonal F and menopause ovaries.
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Candidate entering the ICSI cycle, ages 19 to 41 years, BMI between 18 and 30 AFC greater than or equal to 5 on the third day of the cycle, FSH on the third day of the cycle is less than 12. exclusion criteria: Endometriosis Grade 3 and 4, Ovulation induction contraindications, Severe male factor infertility diagnosis, history of 2 or more previous IVF or ICSI cycles.
Intervention groups
Infertile normoresponder Women Candidate ICSI Cycle,randomly divide in two 40 members groups.First group receive FSH with HCG at triggering time,second group receive only HCG.
Main outcome variables
From the degree of chemical pregnancy (βHCG positive), the rate of implantation (seeing a pregnancy sack in sonography) and the clinical pregnancy rate (seeing fetal heart rate in ultrasound) are examined.

General information

Reason for update
Acronym
FSH for triggering
IRCT registration information
IRCT registration number: IRCT20190108042285N1
Registration date: 2019-01-19, 1397/10/29
Registration timing: registered_while_recruiting

Last update: 2019-01-19, 1397/10/29
Update count: 0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
Nayereh Tamizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23519
Email address
n.tamizi@ari.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-19, 1397/10/29
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision between administration of FSH plus HCG versus HCG alone for triggering ,in the results of ICSI
Public title
FSH for triggering in ICSI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for the ICSI Cycle FSH of the third day of the cycle less than 12 AFC more or equal 5 BMI between 18 and 30
Exclusion criteria:
Infertility with severe male factor A history of twice as many ICSI or IVF Previous cycles Endometriosis Grade 3 and 4 contraIndications for ovulation induction
Age
From 19 years old to 41 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two equal groups (A and B) based on a randomized design with six blocks that are designed using random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study population, taking into account that in the general process of treatment of ICSI, multiple injections of injections (at least 6 days) and only the last injection in the study group receive an additional injection every day (from the same type of ampoule that was received daily from day before Have blinded themselves to what group, study or control are. Data analysis with group A and group B data analysis, so that information on intervention on the user group is not known.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Avicenna Research Institute for Biotechnology, Jahad University
Street address
Shariati St. Tehran, Tehran province, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1397.016

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
The amount and quality of the oocyte is obtained
Timepoint
time of ovary puncture
Method of measurement
embriologist assey

2

Description
chemical pregnancy care
Timepoint
16 days later receive HCG
Method of measurement
beta HCG

Secondary outcomes

1

Description
clinical pregnancy rate
Timepoint
7 weeks of pregnancy
Method of measurement
sonography

2

Description
implantation rate
Timepoint
5 weeks of pergnancy
Method of measurement
sonography

Intervention groups

1

Description
Intervention group: Normally, the women are candidates for the ICSI cycle, and the first group consists of 40 people. In this group, in addition to receiving 10,000 units of HCG, 450 gonal F (FSH) is administered to the Trigger Rur.
Category
Treatment - Drugs

2

Description
Control group: The group, which includes 40 sexually transmitted ICSI candidates, receives 10,000 units of HCG during the trigger.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Avecinna Infertility Treatment Center
Full name of responsible person
Dr Soheila Ansaripour
Street address
SHARIATI
City
TEHRAN
Province
Tehran
Postal code
1941913114
Phone
+98 21 2264 4710
Email
Soh.ansaripour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mohammad Reza Sadeghi
Street address
shariati St.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 2243 2020
Email
Soh.ansaripour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Tamizi Nayereh
Position
infertillity fllowship assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shariati St.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 2264 4710
Email
dr.nayereh.tamizi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Ansaripour Soheila
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shariati St.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 2264 4710
Email
Soh.ansaripour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr.Tamizi.Nayereh
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shariati St.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 2264 4710
Email
dr.nayereh.tamizi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
non ethical
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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