Infertility, Reproductive Disorder, Spermatozoa
Conditions
Keywords
Intrauterine insemination, Ejaculatory abstinence, sperm DNA fragmentation, TUNEL assay
Brief summary
Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The aim of this study was to report the effect of ejaculatory abstinence on sperm DNA fragmentation and pregnancy rates in IUI cycles, as well as the correlation between the two.
Detailed description
Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Several studies have been published over the past few years examining the relationship between sperm DNA fragmentation and IUI outcome. The optimal period for ejaculatory abstinence before the semen sample is a controversial issue in the literature. There are only two retrospective studies examining the relationship between the ejaculatory abstinence period and pregnancy rates after IUI. Several studies suggested performing IUI with sperm samples obtained in a shorter abstinence period than recommended by WHO. However, there isn't enough research on this issue in the literature. Moreover, there is no specific prospective clinical research examining the relationship of ejaculatory abstinence period and sperm DNA fragmentation in IUI cycles. The aim of this study was to report the effect of ejaculatory abstinence on sperm DNA fragmentation and pregnancy rates in IUI cycles, as well as the correlation between the two
Interventions
PROCEDUREINTRAUTERINE INSEMINATION
Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Sperm that have been washed and concentrated are placed directly into the uterus around the time of ovulation. All patients had ovulation induction with gonadotropins and ovulation was triggered by recombinant hcg.
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
From the randomization list, an independent secretary who was blind to patients' identities applied the allocation in consecutive order. Patients allocated into group A, and group B. Care provider and investigator were blind to patient groups. Participants were informed about the timing of abstinence intervals, but they did not know which groups they were allocated to.
Intervention model description
One hundred twenty eligible couples were prospectively randomized into two groups on the second day of the cycle just before starting the treatment protocol. Randomization was performed according to a computer-generated random number list at a ratio of 1:1. From the randomization list, an independent secretary who was blind to patients' identities applied the allocation in consecutive order. Patients allocated into group A, had an ejaculatory abstinence period of one day, whereas patients allocated into group B had an ejaculatory abstinence period of three days.
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Infertility for more than 12 months * Diagnosed as unexplained infertility * Female age between 20 and 40 years * Regular menstrual cycles * Mid-luteal progesterone levels of \>3 ng/ml * Basal FSH \<12 mIU/ml, AMH \>1ng/ml * Body mass index (BMI) 19-35 kg/m2 * No pelvic pathology documented by transvaginal ultrasound and bilateral tubal patency diagnosed by hysterosalpingography * Normal semen parameters according to WHO criteria
Exclusion criteria
* Any endocrine and pelvic pathology * PCOS (polycystic ovarian syndrome) * Known endometriosis history * Prior pelvic surgery * Persistent ovarian cysts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rate | The pregnancy test was done 14 days after intrauterine insemination. If the test was positive, transvaginal ultrasonography was performed at 6-7 weeks of gestation. | The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm DNA fragmentation percentage | On the day of IUI, semen samples were obtained and the sperm DNA fragmentation was measured by the TUNEL method in the inseminated sperm. | Sperm DNA fragmentation rate assessed by TUNEL assay. |
Countries
Turkey (Türkiye)
Outcome results
None listed