Infertility, FemaleNCT01756872
Clinical Measures of Ovarian Reserve in Predicting IVF Success
An observational study of Infertility, Female, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Measurements of ovarian reserve
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women attending the Oxford Fertility Unit planning an IVF/IVF-ICSI treatment cycle
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Accuracy of Clinical Measures of Ovarian Reserve in Predicting Successful In Vitro Fertilisation (IVF)Treatment.
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.
- Conditions
- Infertility, Female
- Being tested
- Measurements of ovarian reserve
- Keywords
- infertility, Assisted reproductive technology, ovarian reserve
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of ovarian reserveProcedure or surgery
Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume
| Study group | Role | What they receive |
|---|---|---|
| Ovarian reserve study participants | Measurements of ovarian reserve for women attending the Oxford Fertility Unit having their first IVF/IVF-ICSI cycle. Receives: Procedure: Measurements of ovarian reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate per cycle
Measured: up to one year after last appointment of final participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Fertility Unit
- Responsible party
- Sponsor
- Investigators
- Tim Child, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756872
- Sponsor's protocol ID
- NDOG-12/SC/0277
- Status last verified
- May 2016
- First submitted
- 20 Dec 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Accuracy of Clinical Measures of Ovarian Reserve in Predicting Successful In Vitro Fertilisation (IVF)Treatment.
- ClinicalTrials.gov ID
- NCT01756872
- Acronym / sponsor ID
- NDOG-12/SC/0277
- Conditions
- Infertility, Female
- Keywords
- infertility, Assisted reproductive technology, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford Fertility Unit
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian reserve study participants | – | Procedure: Measurements of ovarian reserveMeasurements of ovarian reserve for women attending the Oxford Fertility Unit having their first IVF/IVF-ICSI cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women attending the Oxford Fertility Unit planning an IVF/IVF-ICSI treatment cycle
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of ovarian reserveBlood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume | Procedure or surgery | Ovarian reserve study participants |
Primary outcome
Live birth rate per cycle
Time frame: up to one year after last appointment of final participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Child principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate per cycle (time frame: up to one year after last appointment of final participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.