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Efficacy of low-dose hCG adjunct to r-hFSH plus GnRH antagonist for ovarian stimulation in assisted reproductive technology

Protocol summary

Summary
The aim of this study is to evaluate the effect of adding low-dose hCG to GnRH antagonist+r-hFSH protocole on the outcome of ART in the patients undergoing IVF/ICSI cycle. This study is a clinical trial. In all 120 patients pre-treatment with OCP will be given during the cycle prior to the IVF/ICSI. r-hFSH (150-300 IU) will be loaded on either day 2 or 3 of the menstural cycle, and the full dose will be continued until two follicles reach 14-15 mm in size, then daily administration of 0.25 mg of cetrorelix will be started. The starting dose of FSH will be chosen according to patient’s age, BMI, and ovarian responsiveness in previous cycle. according to the study group, patients will receive or will not, a daily injection of hCG (200 IU). when at least 2 follicles reach 18 mm in size, 10000 IU of hCG will be injected and oocyt retrieval will be performed within 35-36 hours. After that, All patients will undergo an ICSI procedure. Luteal phase will be started on the day of oocyt retrieval by vaginal administration of cyclogest 400 mg/day. BhCG will be checked 15 days after oocyte retrieval and pregnancy will be confirmed by pregnancy sac visualization by week 6. Serum E2 level on the day of hCG administration, number of total oocyts, number of mature oocyt, FSH total dose, duration of stimulation, number of good quality embryo, fertilization and pregnancy rate will be compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211197165N2
Registration date: 2012-11-25, 1391/09/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-25, 1391/09/05
Registrant information
Name
Ladan Kashani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 1866
Email address
kashani_ladan@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-02-21, 1391/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of low-dose hCG adjunct to r-hFSH plus GnRH antagonist for ovarian stimulation in assisted reproductive technology
Public title
Efficacy of low-dose hCG adjunct to r-hFSH plus GnRH antagonist for ovarian stimulation in assisted reproductive technology
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infertile female patient; age between 20-39 years old; body mass index(BMI) of 20- 25 kg/m2; a normal uterus and two functional ovaries; day 3 FSH level< 10 IU/L and E2 level< 60 pg/ml.Exclusion criteria: history of > 2 unsuccessful IVF/ICSI attempts; poor ovarian response in previous IVF/ICSI treatment and any endocrine disorders.
Age
From 20 years old to 39 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Ethic Committee of Tehran University of Medical Sciences
Street address
Ethic Committee of Tehran University of Medical Sciences, 16 azar avenue, Keshavarz bolvar
City
Tehran
Postal code
Approval date
2007-04-25, 1386/02/05
Ethics committee reference number
5739

Health conditions studied

1

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

Primary outcomes

1

Description
Beta-hCG level
Timepoint
15 days after oocyte retrieval
Method of measurement
By laboratory kit from blood sample

Secondary outcomes

1

Description
Number of mature oocytes
Timepoint
35-36 hours after high-dose hCG injection
Method of measurement
Transabdominal ultrasound

Intervention groups

1

Description
r-hFSH + GnRH antagonist
Category
Treatment - Drugs

2

Description
r-hFSH + GnRH antagonist + low-dose hCG
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Dr. Ladan Kashani
Street address
Tehran Pars, Rashid Street, Arash Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Foutohi
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Assistant Prof.
Other areas of specialty/work
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Postal code
Phone
+98 21 7788 3195
Fax
Email
Kashani_ladan@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Assistant Prof.
Other areas of specialty/work
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Postal code
Phone
+98 21 7788 3195
Fax
Email
kashani_ladan@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Assistant Prof.
Other areas of specialty/work
Street address
Arash Hospital, Rashid Street, Tehran Pars
City
Tehran
Postal code
Phone
+98 21 7788 3195
Fax
Email
kashani_ladan@tums.ac.ir
Web page address

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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