Clinical Measures of Ovarian Reserve in Predicting IVF Success

Infertility, Female Clinical Trial

Official title:

Determining the Accuracy of Clinical Measures of Ovarian Reserve in Predicting Successful In Vitro Fertilisation (IVF)Treatment.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01756872
• Other study ID #: NDOG-12/SC/0277
• Status: Active, not recruiting
• Phase: N/A
• First received: December 20, 2012
• Last updated: December 2, 2014
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to find out more about tests used to estimate the number of eggs a woman has remaining in her ovaries (her 'ovarian reserve'). It is thought that women who have a greater number of eggs or ovarian reserve may have a better chance of successful in vitro Fertilisation (IVF) treatment than those who have a smaller number of eggs. Accurately predicting the likely outcomes of IVF would be of great benefit for counselling patients before they go through expensive and demanding treatments such as IVF and IVF with Intracytoplasmic sperm injection (IVFICSI).

Over the past two decades, many endocrine and ultrasound markers have been designed and are now used as indicators of ovarian reserve. A number of screening tests are utilized to measure these markers, either by ultrasound scanning techniques or taking blood samples. However it is not yet known which, if any, best predict the outcome of IVF treatment. We would like to investigate these various measures of ovarian reserve to determine which are most accurate, particularly for predicting live birth rates, as up to now only poor to moderate quality evidence has been available for this outcome.

This will be a prospective cohort study of 300 women who already intend to undergo IVF/IVF-ICSI treatment. Study participants will have one extra blood sample and ultrasound examination, for the purposes of measuring markers of their ovarian reserve, at the start of their IVF/IVFICSI treatment cycle. No other interventions will be required and their treatment cycle will not be affected by their participation in the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Female, aged 18 years or above.

• First cycle of ovarian stimulation.

• Suitable for standard 'long protocol' IVF/IVF-ICSI cycle.

Exclusion Criteria:

• The participant does not understand the English language, or has special communication needs. This is because it is impractical to provide, for this small scale study, information sheets and consent forms in other languages except English.

• Patients unsuitable for standard 'long protocol' IVF/IVFICSI cycle

• Presence of endometrioma or any other kind of ovarian cyst > 20mm diameter.

• Presence of Polycystic Ovarian Syndrome.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• Measurements of ovarian reserve
Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume

Locations

Country	Name	City	State
United Kingdom	Oxford Fertility Unit	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford Fertility Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate per cycle		up to one year after last appointment of final participant	No