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CompletedNCT01589016Updated Sep 19, 2013

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

An observational study in Ectopic Pregnancies, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-19.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
96
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Ectopic Pregnancies

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03

In context

Pregnancy, Ectopic

79 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's enrollment of 96 is below the median of 150 across 37 observational studies indexed under Pregnancy, Ectopic.

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Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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.

Eligibility 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
96 participants (actual)
Biospecimen retention
None retained

Groups and cohorts

  • PUL (pregnancy of unknown location),
  • EP ( ectopic pregnancies P)
  • IUP-singleton intrauterine pregnancies
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What researchers measure

Primary outcomes

  1. levels of activin and inhibin A

    Time frame: within the first two weeks after the first control of pregnancy

Secondary outcomes

  1. Progesterone and BHCG

    Time frame: within the first two weeks after the first control of pregnancy

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Study locations

1 site
  • IVI Valencia
    Valencia, 46015, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01589016
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Juan Giles (Gynaecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA) — Principal investigator
First posted
May 1, 2012
Start date
Apr 2012
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Sep 19, 2013

Study contacts

Juan Giles, MD
principal investigator · IVI Valencia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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