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

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Brief Title

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

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 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 Type


Primary Outcome

levels of activin and inhibin A

Secondary Outcome

 Progesterone and BHCG


Ectopic Pregnancies

Study Arms / Comparison Groups

 PUL (pregnancy of unknown location),


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

April 2012

Completion Date

July 2012

Primary Completion Date

July 2012

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




18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Juan Giles, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Sponsor

Juan Giles, MD, Principal Investigator, IVI Valencia

Verification Date

September 2013