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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
Sponsor:
Information provided by (Responsible Party):
Juan Giles, Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Description
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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 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

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


Outcome Measures
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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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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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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


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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Responsible Party: Juan Giles, Gynaecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
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