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

Learn more about:
Related Clinical Trial
Medical Treatment in Ectopic Tubal Pregnancy Evaluation of Different Doses of Letrozole in Ectopic Pregnancy Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment. Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task Expectant Management of Ectopic Pregnancy Psychological Impact of Pregnancy of Unknown Location Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus Cornual Wedge Resection Outcome Pregnancies of Uncertain Location or Viability Research Randomized Population-Based Study on Chlamydia Trachomatis Screening Sonographic Assessment and Visualization of Ectopics in Emergency Medicine Kisspeptin Levels in Early Pregnancy RCT for Women With a Persisting Pregnancy of Unknown Location Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy Vitamin D in Ectopic Pregnancies Laparoscopic Tubal Preservation Surgery BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy Methotrexate Treatment for Ectopic Pregnancy Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy Two-Dose Methotrexate for Ectopic Pregnancy Ectopic Pregnancy Biomarkers The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy? Risk Factors of Ectopic Pregnancy Assessment of Biomarkers in Ectopic Pregnancy Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

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

Observational


Primary Outcome

levels of activin and inhibin A

Secondary Outcome

 Progesterone and BHCG

Condition

Ectopic Pregnancies


Study Arms / Comparison Groups

 PUL (pregnancy of unknown location),
Description:  

Publications

* 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

96

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
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Juan Giles, MD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01589016

Organization ID

0711-C-033-JG


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