Predictive evaluation of DFI in response rate to treatment with FSH
Design
clinical trial without control group with single groups and not blinded
Settings and conduct
This clinical study is conducted on infertile male patients referring to urology clinic of Imam Reza Hospital in Mashhad. All patients with take the test of sperm DNA fragmentation index and will then, based on the DNA damage, be divided into 3 groups:
1- Group with SDI of lower than 0.15 (excellent fertility)
2- Group with SDI of 0.15 to 0.3 (medium fertility)
3- Group with SDI of higher than 0.3 (poor fertility)
All patients under study with Spermogram are required to take hormone tests which include measurement of FSH, LH, and testosterone levels in addition to DNA Fragmentation Index (DFI) test. All patients will also be clinically examined in order to be sure there is no structural problem
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient has an infertility problem, Patient is not under any other treatment or does not have any indication of surgery, oligoasthenospermia, Patient does not have any background anatomical problems in urogenital system, Patient's spouse is absolutely healthy in terms of fertility and has no problems
Exclusion criteria: Creation of any anatomical disorder like Varicocele in urogenital system during the research, History of any previous medical intervention or previous surgery
Intervention groups
Use of subcutaneous FSH in treatment of idiopathic oligoasthenospermia every other day for 6 months with dosage of 150 mg and comparison of Spermogram factors, hormone profile and sperm DNA damage before and after treatment
Main outcome variables
Spermogram, DNA fragmentation index (DFI), complications, hormone tests
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N28
Registration date:2019-07-14, 1398/04/23
Registration timing:prospective
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the response to treatment with FSH in patients with oligoasthenospermia with different levels of DFI
Public title
Evaluation of the effect of FSH in treatment of oligoasthenospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient has an infertility problem
Patient is not under any other treatment or does not have any indication of surgery
oligoasthenospermia
Patient does not have any background anatomical problems in urogenital system
Patient's spouse is absolutely healthy in terms of fertility and has no problems
Exclusion criteria:
Creation of any anatomical disorder like Varicocele in urogenital system during the research
History of any previous medical intervention or previous surgery
Age
From 20 years old to 45 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-04-16, 1398/01/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.175
Health conditions studied
1
Description of health condition studied
Oligoasthenospermia
ICD-10 code
R86.9
ICD-10 code description
Unspecified abnormal finding in specimens from male genital organs
Primary outcomes
1
Description
Spermogram
Timepoint
before and after treatment (6 months after medication use)
Method of measurement
Laboratory sampling
2
Description
Test of DNA damage in sperm (DNA fragmentation index)
Timepoint
before and after treatment (6 months after medication use)
Method of measurement
Laboratory sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of subcutaneous FSH in treatment of idiopathic oligoasthenospermia every other day for 6 months with dosage of 150 mg and comparison of Spermogram factors, hormone profile and sperm DNA damage before and after treatment