Status:
ACTIVE_NOT_RECRUITING
Adenomyosis and Pregnancy Outcomes in Women Undergoing Assisted Reproductive Technology Treatment
Lead Sponsor:
CARE Fertility UK
Collaborating Sponsors:
University of Birmingham
Conditions:
Adenomyosis
Infertility
Eligibility:
FEMALE
18-45 years
Brief Summary
Rationale: A rising number of adenomyosis cases are being diagnosed in women in the age group of 30 to 40 years. This is due to a combination of better diagnostic imaging techniques and a higher numbe...
Detailed Description
The study investigators propose a prospective observational study to determine the association between adenomyosis and pregnancy loss in women undergoing ART treatment using a consistent classificatio...
Eligibility Criteria
Inclusion
- Age \>18 years and ≤42 years: Maternal age is an independent factor affecting the live birth rate in ART cycles. In 2019, a steep drop in the live birth rate has been reported in the United Kingdom in the latest Human Fertilisation and Embryology Authority (HFEA) data from the 32% per embryo transferred for patients under 35 years, compared to below 5% for patients aged 43+ when using their own eggs (HFEA, 2021). Hence, this is the age cut-off used in the study.
- Undergoing IVF/ICSI cycle.
Exclusion
- Coexisting fibroid uterus. The sensitivity of TVUS for diagnosis of adenomyosis gradually decreases to as low as 33% when fibroids are present (Chapron et al, 2020; Dueholm et al, 2001) and hence this is a reasonable exclusion criterion due to risk of confounding.
- Endometriosis: Endometrioma confirmed on USS or known laparoscopic diagnosis of endometriosis (with histological confirmation). This will not fully exclude endometriosis in all the participants included in the study and inclusion of these potential missed cases of endometriosis will be one of the limiting factors of the study.
- Untreated hydrosalpinx
- Uterine malformation
- Previous myomectomy
- Previous surgery for adenomyosis
- Inconclusive USS
- September 2022: Amendments to the protocol: Some of the methodological aspects of the AdAPT-ART study have been revisited to ensure timely delivery of the study to a full sample size and to make the recruitment smooth. These amendments have been approved by the local ethics committee.
- Amendment to the eligibility criteria: Inclusion:
- Age: 18-45 years (Age will be adjusted for)
- Endometriosis: Subgroup analysis for isolated adenomyosis and those with coexisting endometriosis will be performed
- Rationale: Adenomyosis with coexisting endometriosis is common and is an important group to look at in terms of outcome of pregnancy loss.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
828 Patients enrolled
Trial Details
Trial ID
NCT05418140
Start Date
June 14 2022
End Date
December 31 2025
Last Update
March 12 2025
Active Locations (9)
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1
CARE Fertility, Birmingham
Birmingham, England, United Kingdom, B15 3DP
2
CARE Fertility, Chester
Chester, England, United Kingdom, CH2 1UL
3
CARE Fertility, Manchester
Manchester, England, United Kingdom, M14 5QH
4
CARE Fertility, Nottingham
Nottingham, England, United Kingdom, NG8 6PZ