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Effect of Adenomyosis on In Vitro Fertilisation - Embryo Transfer (IVF-ET) outcomes.

The effect of sonographically diagnosed adenomyosis on the outcome of In Vitro Fertilisation-Embryo Transfer.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000796381
Enrollment
860
Registered
2017-05-31
Start date
2016-01-01
Completion date
2018-09-30
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Adenomyosis is a condition characterised by the presence of endometrial lining/glands and stroma in the muscle wall of the uterus with surrounding swelling. Typically patients present clinically with a combination of abnormal uterine bleeding, secondary period pain and a tender enlarged uterus in the fourth and fifth decades of life. Infertility is a less common presentation, however as many women are delaying having children into their late thirties and fourties, adenomyosis is increasingly encountered during the clinical work up of infertile women. A definitive link between adenomyosis and infertility has not been established, however several studies have demonstrated a strong association between the two. A recent study looking at uterine wall thickness found that in vitro fertilisation and embryo transfer (IVF-ET) outcomes decreased with increasing uterine wall thickness and findings suggestive of adenomyosis, however two small trials of IVF-ET in patients with adenomyosis found no difference in pregnancy outcomes compared to matched cases. , There is therefore limited and conflicting evidence for the effectiveness of IVF-ET in patients with adenomyosis. The aim of this trial is to evaluate the outcomes of IVF-ET (InVitro Fertilisation - Embryo Transfer) in patients with an ultrasound diagnosis of adenomyosis. The primary hypotheses are that: 1. IVF-ET success rates (clinical pregnancy & live-births) will be different in women with adenomyosis compared to those without adenomyosis based on ultrasound. 2. That the above finding will be true regardless of whether adenomyosis is the only cause or one of multiple causes of infertility in the female. The secondary hypotheses are that: 1. The presence of adenomyosis will be associated with altered 1a. Implantation rates. 1b. Miscarriage rates per clinical pregnancy. 1c. Ectopic pregnancy rates per clinical pregnancy.

Interventions

Adenomyosis is a condition characterised by the presence of heterotopic endometrial glands and stroma in the myometrium with surrounding myometrial hyperplasia. Patients undergoing fertility treatment at Monash IVF all have baseline pelvic ultrasound scan. Patients with Adenomyosis will be identified by ultrasound criteria including a combination of: Uterine enlargement in the absence of leiomyomas. Asymmetric enlargement of the anterior or posterior myometrial wall. Lack of contour abnormali

Adenomyosis is a condition characterised by the presence of heterotopic endometrial glands and stroma in the myometrium with surrounding myometrial hyperplasia. Patients undergoing fertility treatment at Monash IVF all have baseline pelvic ultrasound scan. Patients with Adenomyosis will be identified by ultrasound criteria including a combination of: Uterine enlargement in the absence of leiomyomas. Asymmetric enlargement of the anterior or posterior myometrial wall. Lack of contour abnormality or mass effect. Heterogeneous, poorly circumcised areas within the myometrium. Hyperechoic islands or nodules, finger-like projections or linear striations. Anechoic lacunae or cysts of varying size. Increased echo texture of the myometrium. All patients will undergo a stimulated fertility cycle and invitro-fertilisiation/embryo transfer (IVF ET) at Monash IVF. The type of fertility cycle will be determined by the patients treating clinician and may be GnRH agonist or GnRH antagonist based, but all cycles must involve an embryo transfer. Following each embryo transfer (ET), patients will be followed for a maximum of 9 months.

Sponsors

Monash IVF
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

All women treated for infertility by Monash IVF over the next 2 years who: 1. Are aged 18 – 45 2. Are on their first egg collection cycle 3. Have a fresh ET on Day 5 following a down regulation or antagonist cycle 4. Have an US study at Monash Ultrasound for Women within 6 months of IVF-ET (Baseline US) 5. Have any cause of infertility 6. Have complete study data on Monash IVF database (up to birth if pregnant) 7. Used their own eggs Adenomyosis as diagnosed on ultrasound by a tertiary level COGU or board certified Obstetrician and Gynaecologist using their normal US technique and having findings of any of: 1. Uterine enlargement in the absence of leiomyomas 2. Asymmetric enlargement of the anterior or posterior myometrial wall 3. Lack of contour abnormality or mass effect 4. Heterogeneous, poorly circumcised areas within the myometrium 5. Hyperechoic islands or nodules, finger-like projections or linear striations 6. Anechoic lacunae or cysts of varying size 7. Increased echo texture of the myometrium Cause of Infertility: 1. Male factor 2. Endometriosis 3. Ovulation disorder 4. Tubal factor 5. Unexplained 5a. All cases not able to be accommodated in other group.

Exclusion criteria

Not within the inclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 16, 2026