Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology
The purpose of this study is to determine the predictive value of a single serum determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in Vitro Fertilization (IVF) cycles, in both native and donated oocytes.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Single Determination of Serum Activin A and Inhibin A in Predicting the Outcome of Pregnancies of Unknown Location (PUL) After IVF and Oocyte Donation.|
- levels of activin and inhibin A [ Time Frame: within the first two weeks after the first control of pregnancy ] [ Designated as safety issue: No ]
- Progesterone and BHCG [ Time Frame: within the first two weeks after the first control of pregnancy ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
Blood samples are to be taken at the time of the first ultrasound examination and stored at -20ºC. Inhibin A and activin A to be determined by ELISA. β-hCG and P were also determined using Microparticle Enzyme Inmunoassay (MEIA).
|Study Start Date:||April 2012|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|PUL (pregnancy of unknown location),|
|EP ( ectopic pregnancies P)|
|IUP-singleton intrauterine pregnancies|
Ectopic pregnancy (EP) is one of the most common pathologies seen in emergency gynaecology practice. Early diagnostic of this situation is a clinical objective because it remains an important cause of maternal morbidity and mortality worldwide. Currently, transvaginal ultrasound scan (TVS) allow ascertain the location of the pregnancy. However, the diagnosis of EP is complicated by a nonspecific clinical presentation and the inconclusive results in some cases of transvaginal ultrasound at first presentation. For this reason several biomarkers have been investigated to accurately detect the establishment of pregnancy and predict its outcome as early as possible.
These biomarkers include: markers of abnormal embryo/trophoblast growth (β-subunit of HCG, Activin A, etc), markers of abnormal corpus luteum function (progesterone, inhibin A, etc), markers of a growing pregnancy in the Fallopian tube (creatine kinase, vascular endothelial growth factor, etc), markers of inflammation and peritoneal irritation (cancer antigen 125, interleukin-6, etc), and uterine markers of normal implantation (leukaemia inhibitory factor and glycodelin). Β-HCG and progesterone are usually used in clinical practice and activin A and inhibin A have recently shown promising results.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589016
|Valencia, Spain, 46015|
|Principal Investigator:||Juan Giles, MD||IVI Valencia|