Ultrasonographic Hydrotubation versus No Hydrotubation Before Intrauterine Insemination

INTRODUCTION

After failure of anticipated therapy, intrauterine insemination (IUI) is regarded as the initial therapeutic choice for people with unexplained infertility. ¹

In partners with unexplained infertility, intrauterine insemination is normally done for a few cycles before turning to IVF. ²

The gestation rates each cycle with IUI is generally considered to be rather low. ³

ovarian stimulation with IUI, which greatly boosted the likelihood of pregnancy in couples with unexplained infertility, was one of many strategies tested to enhance the result of IUI. ¹

Tubal flushing or hydrotubation, has previously been shown to improve the chances of attaining pregnancy in couples with UI or who are in the initial phases of endometriosis. ⁴

Hydrotubation may have a physical and immunological influence on fertility, such as

inhibiting spermatozoa phagocytosis and changing levels of peritoneal factors like cytokines. ⁵

The goal of the research was to compare the effects of simple hydrotubation with 20 mL of saline and lidocaine one day before IUI vs no hydrotubation on pregnancy rates in individuals with unexplained infertility.

PATIENTS AND METHODS

Administrative and Ethical Design: An Official permission was obtained from Faculty of Medicine. An official permission was obtained from obstetrics and gynaecology department at Al Azhar University Hospitals. Al Azhar University's faculty of medicine's ethics committee has given its approval (Institutional Research Board IRB)

Study design: 214 women with unexplained infertility who visited Alzhar University Hospitals' Gynecology Outpatient Clinics between April and December 2021 were enrolled in this prospective randomized controlled research.

Type of study: Prospective randomized controlled study. Eligible patients who attended infertility devices during the study period was enrolled in the research. They were randomly divided into two treatment groups (group A, Hydrotubation and group B, No Hydrotubation). A web computerized program used Statified blocked randomization method (1:1 ratio) was used for patients' allocation.

Justification of sample size: Assuming that conception rate in Hydrotubation 20.7 and non Hydrotubation is 10.3% so the sample size will be 214 (107 in each group) using epi info at power 80% and CI 95%, where n is the needed sample size in each group (i=1,2), Z is the value from the standard normal dispersion indicating the confidence level to be utilized, and E is the intended margin of error. σ again represents the result variable's standard deviation. Remember from the confidence intervals module that we utilized Sp, the pooled estimate of the basic standard deviation, as a measure of variability in the result when generating a confidence interval estimate for the variance in means (based on pooling the data), where Sp is computed as follows:

Inclusion criteria: All patients were under the age of 40, had been diagnosed with unexplained infertility for at least 24 months, had a body mass index of 25±4 Kg/m2, had patent fallopian tubes verified by hysterosalpingography and/or laparoscopy, and had a good semen assay as per modified WHO standards.

Exclusion criteria: -

Other reasons for infertility, liver or kidney diseases, patients with chronic medical diseases as HTN, DM, Thyroid diseases, hypersensitivity to lidocaine, past hisory of Hyper ovarian stimulation syndrome and patients with abnormal uterine lesions detected by ultrasound as fibroid, polyp, adenomyosis, HSG or hysteroscopy.

Patient preparation: -

The following was performed on all patients: It was taken before the start of the study. No risks were found and any unexpected risk appearing during the study was cleared to the patients and the committee on time. All the records were confidential. The results of this study were used only in scientific purpose. The participation was voluntary, and the patients can discontinue participation at any time without penalty or loss of benefits.

Full history taking with emphasis on: Personal history, complaint Duration – Type of infertility, menstrual History: Frequency, duration, recent change in interval or duration, hot flushes, dysmenorrhea, contraceptive use: Type – Duration – TTP interval, sexual: Coital Frequency, timing, and dyspareunia, obstetric History: TTP interval – Pregnancy complication – Birth details, social History: lifestyle factors as eating habits, weight gain, smoking, alcohol consumption and drug abuse and environmental factors: environmental contaminants or toxins endocrine-disrupting chemicals (EDCs) as agricultural pesticides and herbicides, present History: symptoms of hyperprolactinemia, androgen excess or thyroid disease, and chronic pelvic pain, medications include over-the-counter agents, such as NSAIDs that may adversely affect ovulation. Herbal remedies, past History, medical and Gynecological: endometriosis, recurrent ovarian cysts, leiomyomas, sexually transmitted disease or PID, pelvic and Abdominal surgeries, especially if linked to endometriosis or adhesion formation and ethnicity and familial history of both partners influences the need for periconceptional testing.

Examination:

General Examination: Vital sign especially blood pressure, height, and weight (BMI), built and fat distribution (masculine-feminine) is recorded, thyroid and breast examination were performed, abdomen: Hair distribution, scars, etc and pelvic Examination: Vulva and vagina: any abnormalities noted, Cervix: Direction, shape, scars and any abnormalities (pin-hole OS, previous cervical surgeries, etc.), Uterine tenderness, size, shape (symmetrical or asymmetrical enlargement), Adnexa for masses or tenderness suggestive of ovarian mass or PID and DP for masses or tenderness suggestive of chronic PID.

Pelvic Ultrasound: A bladder full of urine was excellent for TA imaging of pelvic contents.

Transabdominal (TA): The transabdominal approach comprised of midline sagittal and parasagittal pictures oriented from the midline to both hemipelves' peripheries.

Transvaginal (TV): When compared to normal TA imaging (near 3.5 MHz), TV scans employed extended transducers with high frequencies components in the range of 7 MHz to 8 MHz

Blood test for Hormonal profile including (Serum FSH, LH, Estradiol, TSH, Prolactin, and AMH) by Venous blood was obtained from the patients

Before hydrotubation, all patients were tested for bacterial vaginosis, Chlamydia trachomatis, and Neisseria gonorrhoeae, and positive cases were medically treated.

Method:  

One day before to IUI, hydrotubation was performed. Using an empty bladder, the patient was positioned in the lithotomy posture, the cervix was opened with a Cusco speculum, and the portio was cleansed with a swab saturated with saline.

Fig. 1: Cusco Speculum

A pediatric Foley catheter (8F) was placed into the cervical canal, and the catheter balloon was inflated with 0.5–1 cc saline before being pushed against the cervix to ensure minimum leaking. To produce a concentration of 0.1 mg Lidocaine/ml saline, 0.1 cc of 2 percent Lidocaine (Debocaine 2 percent, El-Debeiky Pharma, Egypt) was combined with 19.9 cc of saline. The sonographic hydrotubation procedure was carried out gently and methodically. The patient was told to relax for 10 minutes before returning the following day for IUI.

Posthydrotubation: Intrauterine insemination was accomplished utilizing an intrauterine catheter (Wallace or Cook IUI catheters) linked to a 2 ml syringe 24 hours after hCG treatment. After 2–4 days of sexual abstinence, sperm was collected via masturbation into a sterile container. For semen preparation, the conventional swim-up approach was utilized.

Fig. 2: Wallace Catheter

Statistical Analysis: For data processing, SPSS version 23 was utilized to validate, input, and analyze the data. The findings of this investigation were analyzed using the following statistical approaches. For qualitative variables, data were reported as number and proportion, and for quantitative variables, mean + standard deviation (SD).

RESULTS

573 cases were recruited in our department, 359 cases were excluded and 214 cases were included. With 1:1 ratio allocation all included patients were allocated into two groups, group A with 107 patients and group B with 107 patients.

BMI: Basal Metabolic Index. 1: t-test|2: Chi square test. P > 0.05 is considered non-significant.

Continuous Data represented as Mean (SD)|Discrete data represented as number (percentage)

Table 1: General demographic characteristics of included patients in both groups

In terms of general features, there was no statistical variation between the two groups.

1: t-test   P > 0.05 is considered non-significant.  Continuous Data represented as Mean (SD)|Discrete data represented as number (percentage).

Table 2: Intrauterine insemination cycle characteristics

There was no statistical variation between the included groups according to intrauterine insemination cycle characteristics.

E2: Estradiol hormone. 2: Chi square test. P > 0.05 is considered non-significant.

Continuous Data represented as Mean (SD)|Discrete data represented as number (percentage).

Table 3: Characteristics of patients at day of hCG administration.

There was no statistical variation between the included groups according to Characteristics of patients at day of hCG administration.

2: Chi square test.  P > 0.05 is considered non-significant. Data represented as number (percentage).

Table 4: Complications occurrence in both groups

Concerning the incidence of complications, there was no substantial distinction between the included groups. Hard intubation was in 13 (12.15) cases.

OHSS: Ovarian hyperstimulation syndrome. 2: Chi square test.  P < 0.05 is considered significant.

P > 0.05 is considered non-significant. Data represented as number (percentage).

Table 5: Treatment outcomes in both groups

There was a substantial distinction in treatment results across the included groups. In group A, clinical pregnancy was found in 50 (46.7 percent) of the individuals. In terms of ectopic pregnancy, there was no statistically substantial variation between the groups. No OHSS was observed in both groups.

Fig. 3: Pain intensities measured by visual analog scale (VAS) score in Hydrotubation group

In the Hydrotubation group, the majority of patients (38.3%) had minor discomfort as measured by the visual analog scale (VAS) score. No pain was felt in 39 patients (36.44%). No patient felt severe pain. Only 90 patients completed VAS test during follow up.