History
# Registration date Revision Id
3 2021-03-22, 1400/01/02 176040
2 2021-03-02, 1399/12/12 174197
1 2017-09-22, 1396/06/31 20672
Changes made to previous revision
This is the first revision

Protocol summary

Summary
This study is a randomized clinical trial . The aim of this study is comparison between FSH (follice - stimulating hormone) administration with HCG(human chorionic gonadotropin) at the time of trigger and HCG alone in IVF cycles outcomes. Inclusion criteria : infertile women who candidate for IVF cycles. Exclusion criteria : women with history of endocrine disorders; serum estradiol>4500 pg/ml in day of trigger;intrauterine abnormality( uterine polyp; uterine myoma).110 infertile women who are candidated for IVF(Invitro fertilization) cycles . They divide in 2 proups : Both of two groups receive antagonist protocol.serum estrogen is checked in day of trigger and patient with estradiol >4500 exclude of study. In case group ,patient receive 450 u FSH(cinnal f) with HCG at the time of trigger.36 hours later in both group,oocyte retrieval is done . Main outcomes: pregnancy test (serum BHCG) is done 2 weeks after ET(chemical pregnancy) . Fetal heart beat is checked 2-3 weeks after positive BHCG test(clinical pregnancy).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082724512N5
Registration date: 2017-09-22, 1396/06/31
Registration timing: registered_while_recruiting

Last update:
Update count: 2
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 358247085
Email address
abbas-aflatoonian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Reproductive Sciences Institute ,Shahid Sadoughi University of Medical Sciences.
Expected recruitment start date
2017-09-21, 1396/06/30
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between FSH administration with HCG at the time of trigger and HCG alone in IVF cycles outcomes.
Public title
Comparison between FSH administration with HCG at the time of trigger and HCG alone in IVF cycles outcomes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Infertile women who candidate for IVF cycles. Exclusion criteria : women with history of endocrine disorders; serum estradiol>4500pg/ml in day of trigger;intrauterine abnormality( uterine polyp; uterine myoma)
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd Reproductive Sciences Institute Shahid Sadoughi University
Street address
yazd Reproductive Sciences Institute,Bouali Ave.,Safaeyeh,Yazd,Iran.
City
Yazd
Postal code
8916877391
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SSU.RSI.REC.1396.7

Health conditions studied

1

Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility,unspecified

Primary outcomes

1

Description
chemical pregnancy
Timepoint
14 days after transfer
Method of measurement
BHCG test

2

Description
clinical pregnancy
Timepoint
2 weeks after positive BHCG
Method of measurement
Transvaginal sonography

Secondary outcomes

1

Description
Fertilization proportion
Timepoint
Post oocyte retrival
Method of measurement
The number of fertilized oocytes divided by the total number of oocytes

Intervention groups

1

Description
Patients in intervention group receive 450 IU FSH with 5000 iu HCG on trigger time.
Category
Treatment - Drugs

2

Description
In control group, patients only use HCG 5000 Iu for triggering.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Dr. Abbas Aflatoonian,Professor of Shahid Sadoughi University of Medical Sciences
Street address
Yazd Reproductive Sciences Institute,Bouali Ave. Safaeiyeh,Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd Reproductive Sciences Institute,Shahid Sadoughi University
Full name of responsible person
Prof.Abbas Aflatoonian,Infertility Fellowship
Street address
Yazd Reproductive Sciences Institute,Bouali Ave. Safaeiyeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Reproductive Sciences Institute,Shahid Sadoughi University
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
Yazd Reproductive Sciences Institute
Full name of responsible person
Pro. Abbas Aflatoonian
Position
Professor
Other areas of specialty/work
Street address
Yazd Reproductive Sciences Institute,Bouali Ave. Safaeiye
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 82470873
Email
abbas_aflatoonian@yahoo.com
Web page address
www.yazd_RSI.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Reproductive Sciences Institute
Full name of responsible person
Prof. Abbas Aflatoonian
Position
Professor
Other areas of specialty/work
Street address
Yazd Reproductive Sciences Institute,Bouali Ave. Safaeiye
City
Yazd
Postal code
8916877391
Phone
+98 38247985
Fax
+98 82470873
Email
abbas_aflatoonian@yahoo.com
Web page address
www.yaz-RSI.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd Reproductive Sciences Institute
Full name of responsible person
Dr.Saeideh Dashti
Position
Gynecologist
Other areas of specialty/work
Street address
Yazd Reproductive Sciences Institute,Bouali Ave. Safaeiyeh
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 82470873
Email
saeideh_dashti@yahoo.com
Web page address
www.yazd-RSI.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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