Clinical Trial: Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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.

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Current Primary Outcome: levels of activin and inhibin A [ Time Frame: within the first two weeks after the first control of pregnancy ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Progesterone and BHCG [ Time Frame: within the first two weeks after the first control of pregnancy ]

Original Secondary Outcome: Same as current

Information By: Instituto Valenciano de Infertilidad, IVI VALENCIA

Dates:
Date Received: April 27, 2012
Date Started: April 2012
Date Completion:
Last Updated: September 18, 2013
Last Verified: September 2013