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

Single Determination of Serum Activin A and Inhibin A in Predicting the Outcome of Pregnancies of Unknown Location (PUL) After IVF and Oocyte Donation.

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • IVI Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
levels of activin and inhibin A	within the first two weeks after the first control of pregnancy

Secondary Outcome Measures

Outcome Measure	Time Frame
Progesterone and BHCG	within the first two weeks after the first control of pregnancy

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: April 30, 2012
• First Posted (ESTIMATE): May 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Ectopic
• Other Study ID Numbers: 0711-C-033-JG