Ejaculatory Abstinence in IUI Cycles

• Sponsor: Pamukkale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04361292
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 8.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility; Spermatozoa; Reproductive Disorder	Procedure: INTRAUTERINE INSEMINATION	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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 (Participant, Care Provider, 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.
• Primary Purpose: Other
• Official Title: Effect of Ejaculatory Abstinence Period on Sperm DNA Fragmentation and Pregnancy Outcome of Intrauterine Insemination Cycles: A Prospective Randomized Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 30, 2019
• Actual Study Completion Date: Feb 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A: one day abstinence period Patients allocated into group A had an ejaculatory abstinence period of one day	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.
Active Comparator: Group B: three days abstinence period Patients allocated into group B had an ejaculatory abstinence period of three days	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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center	Denizli		Turkey

Sponsors and Collaborators

• Pamukkale University

Investigators

• Principal Investigator: CIHAN KABUKCU, M.D., Department of Obstetrics and Gynecology - Infertility Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Cihan Kabukcu, Assistant Professor, M.D., Pamukkale University
• ClinicalTrials.gov Identifier: NCT04361292
• Other Study ID Numbers: 60116787-020/17327
• First Posted: Apr 24, 2020
• Last Update Posted: Apr 27, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cihan Kabukcu, Assistant Professor, M.D., Pamukkale University: Intrauterine insemination; Ejaculatory abstinence; sperm DNA fragmentation; TUNEL assay
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Apr 27, 2020