Clinical Measures of Ovarian Reserve in Predicting IVF Success
Determining the Accuracy of Clinical Measures of Ovarian Reserve in Predicting Successful In Vitro Fertilisation (IVF)Treatment.
1 other identifier
observational
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 12, 2016
May 1, 2016
3 years
December 20, 2012
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate per cycle
up to one year after last appointment of final participant
Study Arms (1)
Ovarian reserve study participants
Measurements of ovarian reserve for women attending the Oxford Fertility Unit having their first IVF/IVF-ICSI cycle.
Interventions
Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume
Eligibility Criteria
Women attending the Oxford Fertility Unit planning an IVF/IVF-ICSI treatment cycle
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Oxford Fertility Unitcollaborator
Study Sites (1)
Oxford Fertility Unit
Oxford, OX4 2HW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Child
University of Oxford
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
December 28, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 12, 2016
Record last verified: 2016-05