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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan Giles, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01589016
First received: April 27, 2012
Last updated: September 18, 2013
Last verified: September 2013
History of Changes
  Purpose
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
Ectopic Pregnancies

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • levels of activin and inhibin A [ Time Frame: within the first two weeks after the first control of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progesterone and BHCG [ Time Frame: within the first two weeks after the first control of pregnancy ] [ Designated as safety issue: No ]

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).

Enrollment: 96
Study Start Date: April 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
PUL (pregnancy of unknown location),
EP ( ectopic pregnancies P)
IUP-singleton intrauterine 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.

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: April 27, 2012
Last Updated: September 18, 2013
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications

ClinicalTrials.gov processed this record on September 27, 2016