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Clinical Measures of Ovarian Reserve in Predicting IVF Success

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756872
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : May 12, 2016
Oxford Fertility Unit
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment
Infertility, Female Procedure: Measurements of ovarian reserve

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Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Accuracy of Clinical Measures of Ovarian Reserve in Predicting Successful In Vitro Fertilisation (IVF)Treatment.
Study Start Date : June 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Ovarian reserve study participants
Measurements of ovarian reserve for women attending the Oxford Fertility Unit having their first IVF/IVF-ICSI cycle.
Procedure: Measurements of ovarian reserve
Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume

Primary Outcome Measures :
  1. Live birth rate per cycle [ Time Frame: up to one year after last appointment of final participant ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women attending the Oxford Fertility Unit planning an IVF/IVF-ICSI treatment cycle

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756872

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United Kingdom
Oxford Fertility Unit
Oxford, United Kingdom, OX4 2HW
Sponsors and Collaborators
University of Oxford
Oxford Fertility Unit
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Principal Investigator: Tim Child University of Oxford
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Responsible Party: University of Oxford Identifier: NCT01756872    
Other Study ID Numbers: NDOG-12/SC/0277
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by University of Oxford:
Assisted reproductive technology
ovarian reserve
Additional relevant MeSH terms:
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Infertility, Female
Genital Diseases, Male
Genital Diseases, Female