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OpenTrials
Completed

NCT Number: NCT07676682

INVESTIGATİON OF THE EFFECT OF PASSIVE UTERINE STRAIGHTENING WITH A FULL BLADDER IN COMBINATION WITH TRANSABDOMINAL ULTRASONOGRAPHY ON PREGNANCY RATES IN INTRAUTERINE INSEMINATION: A PROSPECTIVE COHORT STUDY

In this prospective study, we aimed to compare the pregnancy outcomes of a classic blind IUI procedure with an empty bladder with a transabdominal ultrasound-guided IUI procedure where the cervicouterine angle was flattened by using a full bladder.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Firat Universty

Elâzığ, 23100, Turkey (Türkiye)

About this study

Intrauterine artificial insemination (IUI) is a procedure in which prepared sperm is placed into the uterine cavity via a catheter to help couples undergoing treatment for unexplained infertility to conceive. Many factors influence the success of IUI. In this prospective study, we aimed to compare the pregnancy outcomes of a classic blind IUI procedure with an empty bladder with a transabdominal ultrasound-guided IUI procedure where the cervicouterine angle was flattened by using a full bladder. This prospective study was conducted at the Firat University Infertility Clinic between 2021 and November 2022. The study included a total of 340 cases diagnosed with unexplained infertility who underwent gonadotropin induction and completed the study. Group 1 (n=169) = Group that underwent blind IUI with an empty bladder, Group 2 (n=171) = Group that underwent IUI with a full bladder under transabdominal ultrasound guidance. Demographic, laboratory, radiological, ovulation induction procedure, and pregnancy outcomes were compared between the two groups. When comparing the two groups, there were no significant differences in age, body mass index (BMI), basal hormone levels, total antral and dominant follicle count, total motile sperm count, and total gonadotropin dose. The amount of insemination fluid that overflowed from the uterine cavity was significantly greater in the full bladder group than in the empty bladder group. However, clinical pregnancy rates were similar in both groups. Performing the intrauterine insemination procedure with a full bladder under transabdominal ultrasound guidance does not positively affect clinical pregnancy rates, except in terms of ease of procedure.

Who can participate

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

Inclusion criteria

  • The woman is aged between 18 and 39 inclusive.
  • Cases with infertility lasting at least 12 months
  • The presence of known medical indications for IUI.
  • Cases with mild to moderate male factor infertility (cases with a total motile sperm count greater than 5 x 10⁶).
  • Cases with ovulatory disorders
  • Cases diagnosed with unexplained infertility
  • Mixed infertility due to the known causes listed above.
  • Patients who have started primary infertility treatment and those who have started secondary infertility treatment.
  • Cases where ovarian stimulation was performed with gonadotropins.
  • The ability to communicate with the couple verbally or in writing.

Exclusion criteria

  • Cases where unilateral or bilateral tubal passage is absent
  • Cases with acute pelvic inflammatory disease
  • Male partners who have fewer than 1 million motile sperm in semen analysis
  • Endometriosis.

Treatment and study plan

filling bladder

Other

filling and emptying the bladder

Primary outcomes

  1. Clinical Pregnancy

    Time frame: two weeks after IUI

    Women were instructed to perform a blood pregnancy test two weeks after IUI and send the result to our infertility clinic.

    If the result was positive, clinical pregnancy was confirmed by transvaginal ultrasound in the seventh week of amenorrhoea to verify the development of an appropriate intrauterine pregnancy.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

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.