Clinical trial NCT01756872: Clinical Measures of Ovarian Reserve in Predicting IVF Success
Official title: Determining the Accuracy of Clinical Measures of Ovarian Reserve in Predicting Successful In Vitro Fertilisation (IVF)Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Keywords: infertility
Assisted reproductive technology
ovarian reserve
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford Fertility Unit
First posted: 2012-12-28
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attending the Oxford Fertility Unit planning an IVF/IVF-ICSI treatment cycle

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.


Eligibility 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.

Primary outcomes:
measure: Live birth rate per cycle
timeFrame: up to one year after last appointment of final participant
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Fertility Unit
Study officials:
affiliation: University of Oxford
name: Tim Child
role: PRINCIPAL_INVESTIGATOR
References: