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Completed

NCT Number: NCT04361292

Ejaculatory Abstinence in IUI Cycles

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Denizli, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrauterine Insemination

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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