Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology
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ClinicalTrials.gov Identifier: NCT01589016 |
Recruitment Status
:
Completed
First Posted
: May 1, 2012
Last Update Posted
: September 19, 2013
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Condition or disease |
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Ectopic 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.
Study Type : | Observational |
Actual Enrollment : | 96 participants |
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. |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Group/Cohort |
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PUL (pregnancy of unknown location), |
EP ( ectopic pregnancies P) |
IUP-singleton intrauterine pregnancies |
- levels of activin and inhibin A [ Time Frame: within the first two weeks after the first control of pregnancy ]
- Progesterone and BHCG [ Time Frame: within the first two weeks after the first control of pregnancy ]
Biospecimen Retention: None Retained

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with pregnancy of unknown location (PUL) diagnosed 22 - 27 days after oocyte retrieval, at first ultrasound routine control (A "pregnancy of unknown location" (PUL) is a term used to classify a women with a positive pregnancy test and an empty uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal ultrasound scan.)
- Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An intrauterine gestational sac containing a fetal pole with visible cardiac activity
- Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac and/or fetal pole with or without cardiac activity

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589016
Spain | |
IVI Valencia | |
Valencia, Spain, 46015 |
Principal Investigator: | Juan Giles, MD | IVI Valencia |
Responsible Party: | Juan Giles, Gynaecologist IVI Valencia, Instituto Valenciano de Infertilidad, Spain |
ClinicalTrials.gov Identifier: | NCT01589016 History of Changes |
Other Study ID Numbers: |
0711-C-033-JG |
First Posted: | May 1, 2012 Key Record Dates |
Last Update Posted: | September 19, 2013 |
Last Verified: | September 2013 |
Additional relevant MeSH terms:
Pregnancy, Ectopic Pregnancy Complications |