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

NCT07676682 | Completed

• 1 other identifier: 2021/07-16
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Passive Uterine Straightening

Keywords

Intrauterine insemination; unexplained infertility; transabdominal ultrasonography; passive uterine straightening; full bladder

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy

  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.

  two weeks after IUI

Study Arms (2)

Empty bladder

In the full bladder group, patients were asked to fill their bladders by drinking water until they felt the need to urinate, thus passively flattening the uterus. Uterine flattening was determined by transabdominal ultrasonography when the angle was ≥120°.

Other: filling bladder

Full bladder

Patients undergoing blind IUI with an empty bladder were asked to empty their bladders by urinating prior to the procedure.

Other: filling bladder

Interventions

filling bladder OTHER

filling and emptying the bladder

Empty bladder; Full bladder

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This prospective, randomised, single-centre study was conducted at the Fırat University Department of Obstetrics and Gynaecology, infertility clinic in Elazığ, Turkey, between 01/06/2021 and 03/11/2022.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat Universty

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (7)

• Sicchieri F, Silva AB, Silva ACJSRE, Navarro PAAS, Ferriani RA, Reis RMD. Prognostic factors in intrauterine insemination cycles. JBRA Assist Reprod. 2018 Mar 1;22(1):2-7. doi: 10.5935/1518-0557.20180002.

  PMID: 29327861 BACKGROUND

• Tomas C, Tikkinen K, Tuomivaara L, Tapanainen JS, Martikainen H. The degree of difficulty of embryo transfer is an independent factor for predicting pregnancy. Hum Reprod. 2002 Oct;17(10):2632-5. doi: 10.1093/humrep/17.10.2632.

  PMID: 12351540 BACKGROUND

• Ayas S, Gurbuz A, Ayaz R, Asoglu MR, Selcuk S, Alkan A, Eren S. Efficacy of passive uterine straightening during intrauterine insemination on pregnancy rates and ease of technique. J Obstet Gynaecol Res. 2012 Jan;38(1):291-6. doi: 10.1111/j.1447-0756.2011.01684.x. Epub 2011 Nov 9.

  PMID: 22070446 BACKGROUND

• Alorf F, Alani S, Steiner N, Dahan MH. How successful is intrauterine insemination after failed IVF? A study of 551 women. Reprod Biomed Online. 2024 Mar;48(3):103684. doi: 10.1016/j.rbmo.2023.103684. Epub 2023 Nov 10.

  PMID: 38271821 BACKGROUND

• Wang R, Danhof NA, Tjon-Kon-Fat RI, Eijkemans MJ, Bossuyt PM, Mochtar MH, van der Veen F, Bhattacharya S, Mol BWJ, van Wely M. Interventions for unexplained infertility: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2019 Sep 5;9(9):CD012692. doi: 10.1002/14651858.CD012692.pub2.

  PMID: 31486548 BACKGROUND

• Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.

  PMID: 25069504 BACKGROUND

• Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.

  PMID: 28760517 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2021
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)