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NCT Number: NCT01756872

Clinical Measures of Ovarian Reserve in Predicting IVF Success

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Oxford Fertility Unit

Oxford, OX4 2HW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measurements of ovarian reserve

Procedure

Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume

Primary outcomes

  1. Live birth rate per cycle

    Time frame: up to one year after last appointment of final participant

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Oxford Fertility Unit

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2012
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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