Ejaculatory Abstinence in IUI Cycles

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361292
• Other study ID #: 60116787-020/17327
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: April 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 29, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Reproductive Disorder
• Spermatozoa

Intervention

Procedure:
• INTRAUTERINE 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.

Locations

Country	Name	City	State
Turkey	Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Jurema MW, Vieira AD, Bankowski B, Petrella C, Zhao Y, Wallach E, Zacur H. Effect of ejaculatory abstinence period on the pregnancy rate after intrauterine insemination. Fertil Steril. 2005 Sep;84(3):678-81. — View Citation

Marshburn PB, Alanis M, Matthews ML, Usadi R, Papadakis MH, Kullstam S, Hurst BS. A short period of ejaculatory abstinence before intrauterine insemination is associated with higher pregnancy rates. Fertil Steril. 2010 Jan;93(1):286-8. doi: 10.1016/j.fertnstert.2009.07.972. Epub 2009 Sep 3. — View Citation

Thomson LK, Zieschang JA, Clark AM. Oxidative deoxyribonucleic acid damage in sperm has a negative impact on clinical pregnancy rate in intrauterine insemination but not intracytoplasmic sperm injection cycles. Fertil Steril. 2011 Oct;96(4):843-7. doi: 10.1016/j.fertnstert.2011.07.356. Epub 2011 Aug 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.