Protocol summary

Summary
This research is done to examine the effect of adding low dose human Chorionic Gonadotropin (hCG) to recombinant Follicular Stimulating Hormone (rFSH) on follicular phase in women undergoing intracytoplasmic sperm injection cycle. This research is randomized double blind controlled clinical trial. Our trial performs in Fateme Zahra Reproductive Research Center in Babol, Iran. Patients with these inclusion criteria: 20 – 40 years old; normal salpingography are selected and randomly divided in three groups. Exclusion criteria include history of previous chronic disease. Patients randomly placed in to three groups of 50 women. In all three groups all patients treated with a dose of 150 International Unit (IU) rFSH per day. In the first group or control group treatment with rFSH will continue until the creation of the oocytes. In the second group when the follicle size become 14 millimeter, rFSH dose reduce to 75 IU per day and treatment starts with 100 IU hCG per day. In the third group when follicle size become 14 millimeter, treatment with rFSH stops and patient treat with 200 IU hCG per day. Gonadotropin administration continues to mature follicles. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU hCG will inject. Thirty six hours later ovarian puncture is performed. Oocyte maturation, ovarian hyperstimulation syndrome and follicular response will compare in three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012932284N1
Registration date: 2017-03-07, 1395/12/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-07, 1395/12/17
Registrant information
Name
Maryam Yeganegi
Name of organization / entity
Babol Univerisity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 3113
Email address
m.yeganegi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences.
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding low dose human Chorionic Gonadotropin (hCG) to recumbinant Follicular Stimulating Hormone (rFSH) on follicular phase in women undergoing intracytoplasmic sperm injection cycle, a clinical trial.
Public title
ٍEffect of human Chorionic Gonadotropin (hCG) on treatment of infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 20 - 40 years old; 1 year history of infertility; candidate for intracytoplasmic sperm injection. Exclusion Criteria: history of chronic disease; abnormal salpingography.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol Univercity of Medical Sciences
Street address
Rohani hospital, Ganjafrooz street, Babol
City
Babol
Postal code
4717647745
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
mubabol.hri.rec.1395.54

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
Follicle size
Timepoint
Daily
Method of measurement
Ultrasonography - Milimeter

2

Description
Mature oocyte
Timepoint
End of Cycle
Method of measurement
Sonography

Secondary outcomes

1

Description
Ovarian Hyperstimulation Syndrome
Timepoint
Daily
Method of measurement
Sonography - Folicle size - Milimeter

Intervention groups

1

Description
In the first group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. Treatment with rFSH will continue until the creation of the oocytes. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU human Chorionic Gonadotropin (hCG) will inject. Thirty six hours later ovarian puncture is performed
Category
Treatment - Drugs

2

Description
In the second group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. When the follicle size become 14 millimeter, rFSH dose reduce to 75 IU per day and treatment starts with 100 IU human Chorionic Gonadotropin (hCG) per day. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU hCG will inject. Thirty six hours later ovarian puncture is performed.
Category
Treatment - Drugs

3

Description
In the third group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. When follicle size become 14 millimeter, treatment with rFSH stops and patient treat with 200 IU human Chorionic Gonadotropin per day. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU hCG will inject. Thirty six hours later ovarian puncture is performed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemezahra Infertility and Reproductive Health Research Center
Full name of responsible person
Dr. Maryam Yeganegi
Street address
Torkmahalle, 3 Km after Mohammad Hassan Khan Bridge, Babol, Mazandaran,Iran
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Babol University of Medical Science
Full name of responsible person
Dr Ali Bijani
Street address
Babol University of Medical Science, Ganjafrooz Street,
City
Babol
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, Babol University of Medical Science
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
Babol University of Medical Science
Full name of responsible person
Dr Maryam Yeganegi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3227 4880
Fax
Email
parastoo0847@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Dr Zahra Basirat
Position
Professor of Gynecology
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8267
Fax
Email
basiratzahra@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Dr Maryam Yeganegi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Rohani Hospital, Ganjafrooz street, Babol
City
Babol
Postal code
Phone
+98 11 3223 8267
Fax
Email
parastoo0847@yahoo.com
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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