Friday, 12 June 2020

Vol.15, JUNE 2020, Effectiveness of a structured Fertility Diagnosis Package

Effectivenesss of a Structured Fertility Diagnosis Package

Sarah Baker – Fertility Midwife, Jackie Loveridge – Senior Fertility Nurse,

Jude Adeghe – Consultant Gynaecologist, Rasiah Sriskandakumar – Senior Clinical Embryologist.

 

Introduction

Without reaching a diagnosis, appropriate treatment of subfertility cannot be rationally determined. Therefore, an effective plan of fertility investigations to establish a diagnosis is a sine qua non for the management of subfertility.

St Jude’s Clinic offers the One Stop Fertility Diagnosis Package to facilitate the TTC (Trying To Conceive) journey for couples. The essence of the package is to assess the keys pillars of fertility – Ovarian reserve / function, tubal patency and sperm quality.

 The package includes:

-         Blood tests for Anti-Müllerian Hormone (AMH) to check reserve of eggs in the ovaries

-         Blood test to check Rubella immunity

-         Pelvic Ultrasound Scan

-         High Vaginal Swab (HVS) to screen for infection

-         HyCoSy (Hysterosalpingo-contrast-Sonography) procedure to assess tubal patency

-         Semen analysis

-         Review by Consultant to discuss results and treatment options

Objectives

Our clinic has been offering this package of investigations for many years but no formal audit has been conducted so far. The reason for conducting this audit is to assess the effectiveness of the package in terms of the following:

·        Reaching a diagnosis  

·        Time taken to complete all tests within the package

·        The range of abnormalities identified by the tests

·        Any complications arising from HyCoSy procedure

·        What treatments those who took up the package went on to have and their relative success rates in conceiving

Data Collection

All women who had HyCoSy procedures at St Jude’s in 2019 were identified by reviewing the theatre record book. These notes were then pulled from file to assess which patients had the one stop package.

Data was collected on the following parameters:

-         Name

-         Patient ID number

-         Age

-         BMI

-         Duration of Infertility

-         AMH result

-         HVS result

-         Pelvic Ultrasound Result

-         HyCoSy findings

-         Semen analysis results

-         Subsequent Fertility Treatment

-         Treatment Outcome

-         Pregnancy Outcome

 

Data Analysis

Data was collated by category to summarise frequencies of different outcomes and calculate percentages for applicable parameters.

Mean values were calculated for patient characteristics to assess the demographic of women included in the audit and cross reference outcome data.

Results

A total of 41 women who took up the One stop Fertility Diagnosis Audit in 2019 were included in the audit. The mean age of the women included in the audit was 33 years (range 20 years – 46 years) and average BMI was 26.5 (range 19.4 – 48.5) . Mean AMH level was 18.0pmol/L (range 0.7 – 85.4pmol/L). 21% of AMH results were classed as low (<5pmol/L). This is an important discovery to best advice patients on the most effective treatment options and ensure they act sooner rather than later to prevent further decline in ovarian reserve.

41% of HVS results came back abnormal (17 out of 41), with results varying from Candida species, Bacterial Vaginosis Grade 2-3, Ureaplasma/mycoplasma and GBS. All abnormal swab results were treated with over the counter treatment or antibiotic cover. By doing so any abnormal flora or bacteria are removed and the chances of conceiving are improved. GPs were informed of GBS positive results for future reference in pregnancy.
As part of the HyCoSy procedure, broad spectrum antibiotics are routinely given intravenously with sedation medication (Cefuroxime 750mcg). Where abnormal HVS results are identified, HyCoSy procedures are postponed to enable adequate time for treatment to be effective.

17% of trans-vaginal Ultrasound Scans identified abnormalities in pelvic anatomy: most commonly Polycystic Appearance of the Ovaries; other abnormalities included the presence of simple ovarian cysts, multicystic ovaries, fibroids and in one case an arcuate uterus.

The vast majority of HyCoSy procedures concluded Bilateral Tubal Patency (85%), only one patient had Bilateral Tubal Blockage (2%). Five patients had one blocked tube and one patent tube (12%).

Semen parameters were normal in 54% of the men included in the audit. The remaining 46% had reduced parameters of some kind. Results varied from marginally reduced parameters in only one parameter, or increased WCC only, to multiple sperm abnormalities requiring ICSI treatment.  Azoospermia was recorded in one case.

50% of patients went on to have simple ovarian induction treatments with clomifene or letrozole tablets after the one stop package. 11% of patients proceeded to have IUDI treatment (all single women or same sex couples), 17% of couples had IVF/ICSI treatment after the one stop package, usually in cases where there was a tubal blockage or semen parameters were reduced.

The remaining 22% of patients had no treatment at all subsequent to the One Stop Diagnosis Package. Some of these women contacted clinic to inform us that they had conceived naturally, however many did not follow up at all, therefore it is unclear is these women conceived and therefore required no further input from St Jude’s or whether they decided not to pursue fertility treatment or to go to another clinic.

Results show that the percentage of patients included in the audit who conceived after taking up the One Stop Fertility Diagnosis Package was 34%. However a further 22% of women had no follow up. Of the 14 couples who conceived, four conceived with no treatment at all (29%), seven couples conceived following simple ovarian stimulation with clomifene or letrozole (all fewer than 4 cycles) (50%) and three couples conceived following IVF or ICSI treatment (maximum one fresh cycle) (21%).

Due to the timescale of the audit, some treatments are still ongoing therefore some outcome data is not yet available.

Discussion

Current guidelines support the use of the investigations included in the one stop fertility diagnosis package.

AMH is a widely recognised blood test to assess ovarian reserve and does not fluctuate based on the timing in the menstrual cycle therefore results are likely to be more reliable in comparison with other hormone levels which fluctuate depending on cyclical changes and reply on patients attending at the right time in their menstrual cycle.

High vaginal swabs are collected in line with guidelines to identify any potential infection prior to the HyCoSy procedure so any abnormal results may be treated to prevent further spread of infection.

Trans-vaginal ultrasound scanning is used to assess pelvic anatomy, looking at the size and contour of the uterus and ovaries, and noting follicular activity and endometrial thickness in reference to the timing in the cycle.

HyCoSy (Hysterosalpingo Contrast Sonography) is an investigation of the fallopian tubes to check if they are open (patent). Ultrasound scanning is used to check for spillage from the fallopian tubes.  It is done under intravenous conscious sedation to ensure it is not painful for patients. It is an alternative to the traditional HSG procedure (X-ray Hysterosalpingography) offered on the NHS and uses X-ray to check for spillage of radio-opaque media from the fallopian tubes.

Semen analysis is carried out by the Senior Clinical Embryologist in line with WHO 2010 standards. All semen parameters are tested including: volume, concentration, count, morphology, motility, pH, agglutination and leucocyte count.

some patients who had no fertility treatment after the one stop package were lost to follow.

Conclusion

The audit supports the use of the One Stop Fertility Diagnosis Package. A number of patients conceived following the package with no treatment at all, which may be partially attributed to the positive effect of the HyCoSy procedure flushing through the Fallopian tubes. Patients are also offered advice at initial consultation and at review on optimum frequency and timing of intercourse which may play a part in improving fertility outcomes for some patients.

In most cases, the tests were completed within 2months.

The package is successful in identifying the fertility status of couples considering fertility treatments and helps to determine which treatments are available to them.

HyCoSy is a safe procedure to assess tubal patency. It is performed under conscious sedation, and well tolerated. There were no complications during and after the procedure, in all cases.

The package is excellent value for money – the package cost is only half of the total cost if the tests were done individually outside the package.  

          KEY POINTS

 

·  The one stop package is successful in reaching a Fertility Diagnosis for patients, with a significant proportion of test results showing some kind of abnormal results, which may then be treated.
- 21% of AMH blood test results were defined as ‘low’
- 41% of High Vaginal Swab results were abnormal
- 15% of HyCoSy results showed problems with tubal patency
- 46% of semen analysis results showed reduced parameters
By diagnosing the problem, appropriate options for fertility treatment can be discussed to maximise your chances of conceiving.

·  34% of couples conceived after the One Stop package, the majority of whom had no treatment at all or simple ovarian induction treatment with tablets and ultrasound monitoring scans.
The One Stop package alone increases your chance of conceiving due to the positive effect of flushing the fallopian tubes through during the HyCoSy procedure, treating abnormal High Vaginal swab results, lifestyle reviews and use of supplements with abnormal Semen Analysis results, and giving advice on preconception health and optimal frequency of intercourse.

·  The package is completely safe.
No patients had any adverse reactions or complications arising from any of the investigations done as part of the One Stop Fertility Diagnosis Package. No patients required additional review appointments or readmission.



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