Ejaculatory Abstinence in IUI Cycles

April 23, 2020 updated by: Cihan Kabukcu, Pamukkale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey
        • Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60116787-020/17327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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