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A comparative study of ultrasonography and luteinization Hormone Surge Detection regarding the timing and outcomes of Intrauterine insemination in infertile couples.

Protocol summary

Summary
In this nonrandomized, not blinded, clinical trial study(phase 2),the purpose was to compare ultrasonography and luteinization Hormone Surge Detection for Timing and outcome of Intrauterine insemination;therefore, 190 patients were selected as candidates for Intrauterine Insemination (IUI) from 20.02.2013 to 19.02.2014 in the study. All patients with normal levels of Prolactin (PRL) & Thyroid-Stimulating Hormone (TSH) were included in the study (according to recent investigation). Females with Abnormal Uterine Bleeding were excluded from the study. In all patients, Transvaginal Ultrasonography (TVS) was performed on the third day of menstruation. Second control sonography was performed on the 11th day of cycle. In group A, from 11th day of menstruation on, patients started checking the urine sample daily at 4-10 Pm by urinary LH Surge kit. The checking has continued as long as a positive test was gained. Then 24 hours after gaining the positive test, the patient was referred for Intrauterine Insemination (IUI). In group B, on the 11th day of cycles, control with an ultrasound was done every other day. When 1-2 follicles of (16- 18 mm) were seen on ultrasound, Human Chorionic Gonadotropin (HCG) was injected and 36-40 hours later, Intrauterine Insemination (IUI) was performed. Two weeks after Intrauterine Insemination (IUI), BHCG was checked and if positive, pelvic sonography would be performed 4 weeks after IUI. Finally, pregnancy rate, ectopic pregnancy, and abortion were recorded and compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121720358N1
Registration date: 2015-10-16, 1394/07/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-16, 1394/07/24
Registrant information
Name
Nahal Nasehi
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7347
Email address
nasehi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of ultrasonography and luteinization Hormone Surge Detection regarding the timing and outcomes of Intrauterine insemination in infertile couples.
Public title
A comparative study of ultrasound and urinary LH surge kit regarding the timing and outcomes of IUI
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 190 patient have been selected as participants for Intrauterine Insemination that have normal level of Prolactin (PRL) & Thyroid-Stimulating Hormone (TSH) (according to recent investigation). Exclusion criteria: Female participants with abnormal Uterine bleeding were excluded from the study
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 190
Randomization (investigator's opinion)
Not 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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences ,Golestan Boulevard
City
Ahvaz
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
ajums.REC.1392.82

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97, N46
ICD-10 code description
Female infertility, Male infertility

Primary outcomes

1

Description
Pregnancy rate
Timepoint
two weeks after IUI
Method of measurement
positive or negitive

Secondary outcomes

1

Description
Ectopic Pregnancy
Timepoint
4 weeks after IUI
Method of measurement
Pelvic ultrasound

2

Description
Abortion
Timepoint
4 weeks after IUI
Method of measurement
Pelvic ultrasound

Intervention groups

1

Description
In Interventional group urinary LH (luteal Hormone) kit, was used. 24 hours after positive kit, IUI (Intrauterine Insemination) was performed.
Category
Treatment - Other

2

Description
In control group, Transe vaginal ultra sound was used when 1 to 2 follicles 16-18 mm was seen on ultrasound 10000 units HCG injected. and the patient, was told for referring just 36-40 hours after doing IUI.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Center of Ahvaz Imam Khomeini Hospital
Full name of responsible person
ِDr. Nahal Nasehi
Street address
Ahvaz Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
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 Ahvaz Jundishapur 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
Department of Gynecology , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nahal Nasehi
Position
MD, Resident of Gynecology
Other areas of specialty/work
Street address
Ahvaz Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 3333 7347
Fax
Email
nahalnasehi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science, faculty of medicine
Full name of responsible person
Mahvash Zargar
Position
Assisstant professor
Other areas of specialty/work
Street address
Ahvaz Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Dr.zargar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nahal Nasehi
Position
MD, Resident of Gynecology
Other areas of specialty/work
Street address
Ahvaz Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 3333 7347
Fax
Email
nahalnasehi@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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