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

Firat University

Status: Completed

Conditions: Passive Uterine Straightening

Treatments: Other: filling bladder

Study type: Observational

Funder types: Other

Identifiers

NCT07676682

2021/07-16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 340 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

340 participants in 2 patient groups

Empty bladder

Description:

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°.

Treatment:

Other: filling bladder

Full bladder

Description:

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

Treatment:

Other: filling bladder