Clinical Measures of Ovarian Reserve in Predicting IVF Success

NCT ID: NCT01756872

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 204 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Infertility, Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ovarian reserve study participants

Measurements of ovarian reserve for women attending the Oxford Fertility Unit having their first IVF/IVF-ICSI cycle.

Measurements of ovarian reserve

Intervention Type: PROCEDURE

Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume

Interventions

Measurements of ovarian reserve

Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oxford Fertility Unit

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Child

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Oxford Fertility Unit

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

NDOG-12/SC/0277

Identifier Type: -

Identifier Source: org_study_id