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

NCT ID: NCT01589016

Last Updated: 2013-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Ectopic Pregnancies

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PUL (pregnancy of unknown location),

No interventions assigned to this group

EP ( ectopic pregnancies P)

No interventions assigned to this group

IUP-singleton intrauterine pregnancies

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Responsible Party

Juan Giles

Gynaecologist IVI Valencia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Giles, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

IVI Valencia

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

0711-C-033-JG

Identifier Type: -

Identifier Source: org_study_id