InfertilityNCT04361292
Ejaculatory Abstinence in IUI Cycles
A study testing INTRAUTERINE INSEMINATION in people with Infertility and Spermatozoa, run by Pamukkale University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Spermatozoa, Reproductive Disorder
- What is being tested?
- INTRAUTERINE INSEMINATION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Any endocrine and pelvic pathology
- PCOS (polycystic ovarian syndrome)
- Known endometriosis history
- Prior pelvic surgery
- Persistent ovarian cysts.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center
Denizli
About this study
Official title: Effect of Ejaculatory Abstinence Period on Sperm DNA Fragmentation and Pregnancy Outcome of Intrauterine Insemination Cycles: A Prospective Randomized Study
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.
Read the 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
- Conditions
- Infertility, Spermatozoa, Reproductive Disorder
- Being tested
- INTRAUTERINE INSEMINATION
- Keywords
- Intrauterine insemination, Ejaculatory abstinence, sperm DNA fragmentation, TUNEL assay
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTRAUTERINE INSEMINATIONProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: one day abstinence period | Active comparator | Patients allocated into group A had an ejaculatory abstinence period of one day Receives: Procedure: INTRAUTERINE INSEMINATION |
| Group B: three days abstinence period | Active comparator | Patients allocated into group B had an ejaculatory abstinence period of three days Receives: Procedure: INTRAUTERINE INSEMINATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy.
Measured: 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 outcomes (1)
Sperm DNA fragmentation percentage
Sperm DNA fragmentation rate assessed by TUNEL assay.
Measured: On the day of IUI, semen samples were obtained and the sperm DNA fragmentation was measured by the TUNEL method in the inseminated sperm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jan 2019
- Primary completion30 Dec 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihan Kabukcu, Pamukkale University
- Investigators
- CIHAN KABUKCU, M.D., Principal investigator, Department of Obstetrics and Gynecology - Infertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361292
- Sponsor's protocol ID
- 60116787-020/17327
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1016/j.fertnstert.2005.03.044.
PubMed 16169402Marshburn 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.
PubMed 19732887Thomson 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.
PubMed 21839433Kabukcu 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.
PubMed 32902676
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ejaculatory Abstinence Period on Sperm DNA Fragmentation and Pregnancy Outcome of Intrauterine Insemination Cycles: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04361292
- Acronym / sponsor ID
- 60116787-020/17327
- Conditions
- Infertility, Spermatozoa, Reproductive Disorder
- Keywords
- Intrauterine insemination, Ejaculatory abstinence, sperm DNA fragmentation, TUNEL assay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: one day abstinence period | Active comparator | Procedure: INTRAUTERINE INSEMINATIONPatients allocated into group A had an ejaculatory abstinence period of one day |
| Group B: three days abstinence period | Active comparator | Procedure: INTRAUTERINE INSEMINATIONPatients allocated into group B had an ejaculatory abstinence period of three days |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- Any endocrine and pelvic pathology
- PCOS (polycystic ovarian syndrome)
- Known endometriosis history
- Prior pelvic surgery
- Persistent ovarian cysts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTRAUTERINE INSEMINATIONIntrauterine 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. | Procedure or surgery | Group A: one day abstinence period, Group B: three days abstinence period |
Primary outcome
pregnancy rate
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.
The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy.
1 secondary outcome
Sperm DNA fragmentation percentage
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Background: PubMed 16169402Jurema 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.
- Background: PubMed 19732887Marshburn 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.
- Background: PubMed 21839433Thomson 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.
- Derived from this study: PubMed 32902676Kabukcu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CIHAN KABUKCU, M.D. principal investigator
Department of Obstetrics and Gynecology - Infertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTRAUTERINE INSEMINATION in people with Infertility and Spermatozoa, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04361292, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.