Ejaculatory Abstinence in IUI Cycles

Pamukkale University

Status: Completed

Conditions: Infertility; Reproductive Disorder; Spermatozoa

Treatments: Procedure: INTRAUTERINE INSEMINATION

Study type: Interventional

Funder types: Other

Identifiers

NCT04361292

60116787-020/17327

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Group A: one day abstinence period

Active Comparator group

Description:

Patients allocated into group A had an ejaculatory abstinence period of one day

Treatment:

Procedure: INTRAUTERINE INSEMINATION

Group B: three days abstinence period

Active Comparator group

Description:

Patients allocated into group B had an ejaculatory abstinence period of three days

Treatment:

Procedure: INTRAUTERINE INSEMINATION