Clinical Measures of Ovarian Reserve in Predicting IVF Success

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Oxford Fertility Unit
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01756872
First received: December 20, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention
Infertility, Female
Procedure: Measurements of ovarian reserve

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Live birth rate per cycle [ Time Frame: up to one year after last appointment of final participant ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756872

Locations
United Kingdom
Oxford Fertility Unit
Oxford, United Kingdom, OX4 2HW
Sponsors and Collaborators
University of Oxford
Oxford Fertility Unit
Investigators
Principal Investigator: Tim Child University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01756872     History of Changes
Other Study ID Numbers: NDOG-12/SC/0277
Study First Received: December 20, 2012
Last Updated: November 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
infertility
Assisted reproductive technology
ovarian reserve

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 21, 2014