AMH in assessing fertility in GTN after treatment
Research type
Research Study
Full title
AMH GTN study - the use of Anti Mullerian Hormone (AMH) in patients treated with chemotherapy for Gestational Trophoblastic Neoplasia (GTN) to predict ovarian reserve and short-term fertility \n\n
IRAS ID
238537
Contact name
Matthew Winter
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Anti Mullerian hormone is being used increasingly as a biochemical predictor of ovarian reserve and fertility. It has been shown that levels are affected variably and diversely by different chemotherapy regimens; however there is no current meaningful data on Anti Mullerian hormone levels in women treated for trophoblastic neoplasia, or on the correlation of such levels with fertility. This study is designed to look at the variation of Anti Mullerian hormone levels in such women during the course of treatment and to evaluate how these correlate with menses and pregnancy. The study will recruit 50 patients and blood samples will be taken at 3 different time-points; pre chemotherapy, 6 weeks post chemotherapy and at 1 year post chemotherapy. Patients will be asked about their menses and a record of any pregnancy events will be taken. At 2 years following completion of chemotherapy, a further questionnaire will determine if the patients have been trying to conceive and any pregnancy events. Summary statistics and logistic regression analysis will be undertaken to test association between Anti Mullerian hormone and return of menses/pregnancy. Receiver operating characteristic curves for prediction thresholds will be constructed for the relationship between Anti Mullerian hormone level and return of menses and/or pregnancy if appropriate. Visual statistics and paired t tests will be utilised to assess the differences in Anti Mullerian hormone levels. Correlation testing and regression analysis will be utilised to explore the relationship between Anti Mullerian hormone and other reproductive hormones. Findings may guide and further inform the care for subsequent women undergoing chemotherapy for this disease.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0881
Date of REC Opinion
24 May 2018
REC opinion
Favourable Opinion