A Study to Measure Anti-Mullerian Hormone for the Prediction of Response to Ovarian Stimulation
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004772
Sponsor Protocol Number: 15-004772
About this study
The purpose of this study is to identify the measurement of anti-mullerian hormone present that can specifically identify a 90% prediction of a poor ovarian response to controlled ovarian stimulation in women presenting to general invitro fertilization clinics for evaluation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- All racial and ethnic backgrounds
- Written informed consent obtained
- ≥ 21 and < 46 years of age at the time of the blood draw
- Undergoing first cycle of ovarian stimulation for IVF or IVF/ICSI
- Regular menstrual cycle between 21 and 35 days, inclusive
- Both ovaries present
- On day 2 to 4 of a spontaneous menstrual cycle within 3 months prior to starting ovarian stimulation
- Blood samples taken by venipuncture for assay of AMH, FSH and estradiol
- Transvaginal ultrasound scan performed to assess the total number of antral follicles (measuring 2 to 10 mm in average diameter)
Exclusion Criteria
- Evidence of polycystic ovary syndrome using the Rotterdam criteria
- Any 2 of the following 3, after exclusion of related disorders
- Oligo- or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries
- Surgically confirmed ovarian endometrioma
- Any ovarian surgery within one year prior to enrollment and study blood draw
- Ovarian cysts or follicles measuring ≥ 20 mm
- Exposure to cytotoxic drugs or pelvic radiation therapy
- Hormonal contraceptive use within two months prior to enrollment and study blood draw
- Currently pregnant
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Charles Coddington, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available