Assisted Reproductive Technology Clinical Trial
Official title:
Diagnostic Value of Sperm DNA Fragmentation and Sperm Morphology for Predicting Outcome of Assisted Reproduction Treatment
All patients will go through an ICSI (intracytoplasmic sperm injection)cycle Monitoring: COH
(controlled ovarian hyperstimulation) will be monitored by transvaginal sonography, and then
the dose of gonadotropin will be adjusted according to the follicle size and number.
Triggering ovulation: when three or more follicles reach >18mm, endometrium triple line
>8mm, both the gonadotropin and agonist injections will be stopped and 10,000 IU of
hCG(human chorionic gonadotropin ) will be given.
Egg collection : 34-36 hour after hCG injection, embryo transfer :48-72 hour after oocyte
retrieval. Luteal phase support: with 100 mg progesterone injection IM daily until the day
of the pregnancy test pregnancy test: 15 days after the embryo transfer. Semen collection
and preparation Semen samples will be collected by masturbation in clean containers, usually
after 2-3 days of abstinence. Each sample will be allowed to liquefy for at least 20 min at
37 °C.
Semen analysis:
Basic sperm parameters including sperm count, concentration, motility and morphology will be
evaluated according to World Health Organization guidelines. After the initial assessment,
ejaculates will be divided into three aliquots. An aliquot of each sample will be used to
assess sperm DNA damage, the second aliquot will be processed by direct swim-up technique (n
30) or zeta test technique (n 30) this will be followed by assessment of DNA damage again in
each sample to measure the difference in DNA damage after processing in each technique then
spermatozoa from the third aliquot will be morphologically analyzed manually using Spermic
stain and a light microscope and will be scored according to WHO
This study will be carried out in private centers for IVF. The aim of this study is to
determine the prognostic value of sperm DNA fragmentation levels before and after semen
processing and sperm morphology in predicting the outcome of assisted reproduction.
60 couples will undergo ICSI cycles in private centers for IVF. All patients will go through
an ICSI cycle. Monitoring: COH will be monitored by transvaginal sonography, and then the
dose of gonadotropin will be adjusted according to the follicle size and number.
Triggering ovulation: when three or more follicles reach >18mm, endometrium triple line more
than 8mm, both the gonadotropin and agonist injections will be stopped and 10,000 IU of hCG
will be given.
Egg collection : 34-36 hour after hCG injection, embryo transfer :48-72 hour after oocyte
retrieval. Luteal phase support: with 100 mg progesterone injection intramuscularly daily
until the day of the pregnancy test.
pregnancy test: 15 days after the embryo transfer. Semen collection and preparation. Semen
samples will be collected by masturbation in clean containers, usually after 2-3 days of
abstinence. Each sample will be allowed to liquefy for at least 20 min at 37 °C.
Semen analysis:
Basic sperm parameters including sperm count, concentration, motility and morphology will be
evaluated according to World Health Organization guidelines . After the initial assessment,
ejaculates will be divided into three aliquots. An aliquot of each sample will be used to
assess sperm DNA damage, the second aliquot will be processed by direct swim-up technique (n
30) or zeta test technique (n 30) this will be followed by assessment of DNA damage again in
each sample to measure the difference in DNA damage after processing in each technique then
spermatozoa from the third aliquot will be morphologically analyzed manually using Spermic
stain and a light microscope and will be scored according to WHO.
DNA fragmentation assay:
The assessment of DNA damage will be measured before and after processing for each sample
using an improved version of the sperm chromatin dispersion test. Samples will be prepared
for analysis. staining step will be required to evaluate the prepared slides. The samples
will be stained with Diff-Quik solution, immersing each slide in Diff-Quik solution I
(eosinophilic) and Diff-Quik solution II (basophilic) for 6 min each, allowed to dry at room
temperature .then the slide will be examined under bright field microscope.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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