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Trial registered on ANZCTR


Registration number
ACTRN12613001124729
Ethics application status
Approved
Date submitted
7/10/2013
Date registered
9/10/2013
Date last updated
9/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does nitric oxide donors increases pregnancy rate in patients undergoing intrauterine insemination for unexplained infertility?
Scientific title
Prospective randomized controlled pilot clinical study to evaluate the effect of nitric oxide donors treatment on pregnancy rate in patients with unexplained infertility undergoing intrauterine insemination
Secondary ID [1] 283365 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unexplained infertility 290263 0
Condition category
Condition code
Reproductive Health and Childbirth 290653 290653 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
unexplained infertility patients were randomized to a control group and a study group. The control group was treated with ovarian stimulation and intrauterine insemination and study group received the same treatment in addition to 20 mg isosorbid mononitrate tablet once daily applied vaginally starting from the fifth day of the cycle with the start of ovarian stimulation till diagnosis of pregnancy in a case of missed period or occurrence of menstruation. Patients were monitored during treatment by vaginal ultrasound and adherence to treatment was confirmed through drug tablet return
Intervention code [1] 288090 0
Treatment: Drugs
Comparator / control treatment
Active control group treated with ovarian stimulation with100 mg clomiphene citrate tablet once daily orally from cycle day 5-9. Follicular growth was monitored by ultrasound and 10.000 IU human chorionic gonadotrophin given intramuscular when one or more follicles >18mm. Intrauterine insemination was 36 hours later after ultrasound confirmation of ovulation
Control group
Active

Outcomes
Primary outcome [1] 290669 0
pregnancy rate
Timepoint [1] 290669 0
In a case of missed period and serum B-hCG and ultrasound diagnosis of pregnancy or occurrence of menstruation
Secondary outcome [1] 305005 0
Uterine artery pulsation and resistant indices measured by three dimensions pulsed power Doppler trans-vaginal ultrasound
Timepoint [1] 305005 0
Day of intrauterine insemination
Secondary outcome [2] 305028 0
Endometrial vascular, flow and vascular flow indices measured by three dimensions (3D) power Doppler trans-vaginal ultrasound, the 3D power histogram facility and the visual organ computer aided analysis (VOCAL).
Timepoint [2] 305028 0
Day of intrauterine insemination

Eligibility
Key inclusion criteria
Unexplained infertility patients defined as the absence of a definable cause for a couple's failure to achieve pregnancy after 12 months of attempting conception despite a thorough evaluation. Inclusion criteria includes: 1- Normal semen analysis. 2- Patent fallopian tubes by HSG and laparoscopy when indicated. 3- Normal ovulation and luteal phase by serum progesterone at cycle days 21-23 of > 10 ng/ml.
Minimum age
20 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving vasodilators.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Package of Social Science (SPSS) version 16.
Result was represented by the mean and the standard deviation. Student t test was used to compare between two independent groups and the Z test to compare between two proportions. P value of < 0.05 was considered significant.
The sample size was calculated according to the equation : N = Z2 x PQ / D2 where N is the minimum sample size required, Z is the area under the curve of normal distribution = 1.96 (constant), P is the proportion of the affected population, Q is the proportion of the non affected population and D is the magnitude of the absolute sampling error that can be tolerated = 0.04 (constant). If unexplained infertility is about 10% of all cases of infertility (20%), then N = (1.96)2 x 0.2 x 0.8 / (0.04)2 x 10 / 100 = 38

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5486 0
Egypt
State/province [1] 5486 0

Funding & Sponsors
Funding source category [1] 288094 0
Hospital
Name [1] 288094 0
Benha university hospital
Country [1] 288094 0
Egypt
Primary sponsor type
Hospital
Name
Benha university hospital
Address
Farid Nada street, Benha, Kalyoupia
Country
Egypt
Secondary sponsor category [1] 286815 0
None
Name [1] 286815 0
Address [1] 286815 0
Country [1] 286815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290018 0
Deparment of OB/GYN, Benha university hospital
Ethics committee address [1] 290018 0
Farid Nada street, Benha, Kalyoupia
Ethics committee country [1] 290018 0
Egypt
Date submitted for ethics approval [1] 290018 0
Approval date [1] 290018 0
Ethics approval number [1] 290018 0

Summary
Brief summary
Unexplained infertility is failure to get pregnant after one year of marriage in spite of normal semen analysis, patent fallopian tubes and normal ovulation. Good blood flow to the uterus is essential for successful implantation and pregnancy. Nitric oxide donors are drugs the release nitric oxide in the body and acts as vasodilators and perfusion enhancer. In this study we tested if its administration increases uterine blood flow and pregnancy rate in unexplained infertility patients treated with ovarian stimulation and intrauterine insemination
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43502 0
Prof Mohamed Abdelrazik
Address 43502 0
Department of OB/GYN, Benha Faculty of Medicine, Benha University, Farid Nada street, Benha, kalyoupia
Country 43502 0
Egypt
Phone 43502 0
+20 013 01223860001
Fax 43502 0
Email 43502 0
[email protected]
Contact person for public queries
Name 43503 0
Mohamed Abdelrazik
Address 43503 0
Department of OB/GYN, Benha Faculty of Medicine, Benha University, Farid Nada street, Benha, kalyoupia
Country 43503 0
Egypt
Phone 43503 0
+20 013 01223860001
Fax 43503 0
Email 43503 0
[email protected]
Contact person for scientific queries
Name 43504 0
Mohamed Abdelrazik
Address 43504 0
Department of OB/GYN, Benha Faculty of Medicine, Benha University, Farid Nada street, Benha, kalyoupia
Country 43504 0
Egypt
Phone 43504 0
+20 013 01223860001
Fax 43504 0
Email 43504 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNitric oxide donors increase the pregnancy rate in patients with unexplained infertility undergoing clomiphene citrate stimulation and intrauterine insemination: a randomized controlled pilot study.2017https://dx.doi.org/10.1080/09513590.2016.1240775
N.B. These documents automatically identified may not have been verified by the study sponsor.