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Management of endometriotic ovarian cyst before in vitro fertilisation (IVF)

Management of endometrioma in asymptomatic subfertile patients prior to in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI): a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35880386
Enrollment
40
Registered
2008-03-27
Start date
2008-01-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Endometrioma Urological and Genital Diseases Endometriosis

Interventions

A total of 40 women with unilateral or bilateral endometriomas who are on the NHS waiting list for IVF will be included in the study. Central randomisation will be employed and one of the investigator

Sponsors

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Ultrasonographic findings of unilateral or bilateral endometrioma measuring greater than or equal to 3 cm in diameter, within six months of commencing IVF treatment 2. Women less than or equal to 40 years

Exclusion criteria

Exclusion criteria: 1. Previous tubal or ovarian surgery (uni- or bi-lateral, including treatment of ectopic pregnancies) 2. Previous controlled ovarian hyperstimulation (COH) cycle ending in cancellation because of inadequate response or where less than four oocytes were retrieved 3. Previous episode of ovarian hyperstimulation syndrome (OHSS), regardless of the degree 4. Concomitant presence of other (i.e., non-endometriotic) ovarian cyst(s) 5. Day 2 - 3 serum follicle stimulating hormone (FSH) levels greater than 10 mIU/mL 6. Women who received any hormonal treatment within six months before commencing COH

Design outcomes

Primary

MeasureTime frame
1. Serum level of FSH and anti-muellerian hormone (AMH) and antral follicle count (AFC) using transvaginal sonography (TVS) on day two of a spontaneous menstrual cycle before intervention (conservative or surgical management of endometrioma six months or less before IVF cycle) and after intervention (immediately before starting COH for IVF cycle) 2. Duration of gonadotropin (FSH) stimulation (days) and number of FSH ampoules used 3. Number of follicles greater than or equal to 15 mm on the day of human chorionic gonadotropin (hCG) administration 4. Number of oocytes retrieved (oocyte retrieval performed by the same operator)

Secondary

MeasureTime frame
1. Number of oocytes fertilised 2. Number of day two embryos available after oocyte retrieval 3. Number of frozen embryos 4. Clinical pregnancy and live birth rates

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026