Ejaculatory Abstinence in IUI Cycles
Primary Purpose
Infertility, Spermatozoa, Reproductive Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
INTRAUTERINE INSEMINATION
Sponsored by
About this trial
This is an interventional other trial for Infertility focused on measuring Intrauterine insemination, Ejaculatory abstinence, sperm DNA fragmentation, TUNEL assay
Eligibility Criteria
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.
Sites / Locations
- Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: one day abstinence period
Group B: three days abstinence period
Arm Description
Patients allocated into group A had an ejaculatory abstinence period of one day
Patients allocated into group B had an ejaculatory abstinence period of three days
Outcomes
Primary Outcome Measures
pregnancy rate
The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy.
Secondary Outcome Measures
Sperm DNA fragmentation percentage
Sperm DNA fragmentation rate assessed by TUNEL assay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04361292
Brief Title
Ejaculatory Abstinence in IUI Cycles
Official Title
Effect of Ejaculatory Abstinence Period on Sperm DNA Fragmentation and Pregnancy Outcome of Intrauterine Insemination Cycles: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
February 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Spermatozoa, Reproductive Disorder
Keywords
Intrauterine insemination, Ejaculatory abstinence, sperm DNA fragmentation, TUNEL assay
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: one day abstinence period
Arm Type
Active Comparator
Arm Description
Patients allocated into group A had an ejaculatory abstinence period of one day
Arm Title
Group B: three days abstinence period
Arm Type
Active Comparator
Arm Description
Patients allocated into group B had an ejaculatory abstinence period of three days
Intervention Type
Procedure
Intervention Name(s)
INTRAUTERINE INSEMINATION
Intervention 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. 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.
Primary Outcome Measure Information:
Title
pregnancy rate
Description
The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy.
Time Frame
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 Measure Information:
Title
Sperm DNA fragmentation percentage
Description
Sperm DNA fragmentation rate assessed by TUNEL assay.
Time Frame
On the day of IUI, semen samples were obtained and the sperm DNA fragmentation was measured by the TUNEL method in the inseminated sperm.
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Couples with the diagnosis of unexplained infertility.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CIHAN KABUKCU, M.D.
Organizational Affiliation
Department of Obstetrics and Gynecology - Infertility Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center
City
Denizli
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16169402
Citation
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. doi: 10.1016/j.fertnstert.2005.03.044.
Results Reference
background
PubMed Identifier
19732887
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.
Results Reference
background
PubMed Identifier
21839433
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.
Results Reference
background
PubMed Identifier
32902676
Citation
Kabukcu C, Cil N, Cabus U, Alatas E. Effect of ejaculatory abstinence period on sperm DNA fragmentation and pregnancy outcome of intrauterine insemination cycles: A prospective randomized study. Arch Gynecol Obstet. 2021 Jan;303(1):269-278. doi: 10.1007/s00404-020-05783-0. Epub 2020 Sep 9.
Results Reference
derived
Learn more about this trial
Ejaculatory Abstinence in IUI Cycles
We'll reach out to this number within 24 hrs