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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Ectopic Pregnancies

Detailed Description:

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
PUL (pregnancy of unknown location),
EP ( ectopic pregnancies P)
IUP-singleton intrauterine pregnancies

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. levels of activin and inhibin A [ Time Frame: within the first two weeks after the first control of pregnancy ]

Secondary Outcome Measures :

1. Progesterone and BHCG [ Time Frame: within the first two weeks after the first control of pregnancy ]

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).

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

In the first control, made 22-27 days after oocyte retrieval, all women underwent a transvaginal ultrasound (TVS) examination using a 6.5-MHz transducer (Voluson 730 Pro V; General Electric, Madrid, Spain). They were diagnosed with an ectopic pregnancy (EP) or an intrauterine pregnancy (IUP) on the basis of this examination and where there was no clear ultrasound evidence of pregnancy were classified as pregnancy of unknown location (PUL). Women were followed up until the final pregnancy outcome was known.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
IVI Valencia
Valencia, Spain, 46015

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

Principal Investigator:	Juan Giles, MD	IVI Valencia

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	September 19, 2013
Last Verified:	September 2013

Additional relevant MeSH terms:

Pregnancy, Ectopic; Pregnancy Complications