Ejaculatory Abstinence in IUI Cycles

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Ejaculatory Abstinence Period on Sperm DNA Fragmentation and Pregnancy Outcome of Intrauterine Insemination Cycles: A Prospective Randomized Study

Conditions
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Infertility, Spermatozoa, Reproductive Disorder

Intervention / Treatment
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* Procedure: INTRAUTERINE INSEMINATION


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: one day abstinence period<br>Patients allocated into group A had an ejaculatory abstinence period of one day | Procedure: INTRAUTERINE INSEMINATION<br>* 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.<br>|
| Active Comparator: Group B: three days abstinence period<br>Patients allocated into group B had an ejaculatory abstinence period of three days | Procedure: INTRAUTERINE INSEMINATION<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm DNA fragmentation percentage | Sperm DNA fragmentation rate assessed by TUNEL assay. | On the day of IUI, semen samples were obtained and the sperm DNA fragmentation was measured by the TUNEL method in the inseminated sperm. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine insemination, Ejaculatory abstinence, sperm DNA fragmentation, TUNEL assay