Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

June 2, 2016 updated by: IVI Vigo

Retrospective Cohort Study of Increased Risk of Ectopic Pregnancy Associated With Marked Variation of Estradiol During the Early Luteal Phase and High Progesterone on hCG Day in IVF

This study evaluates the increased risk of ectopic pregnancy associated with marked variation of estradiol during the early luteal phase and high progesterone on hCG day in IVF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective cohort study of 578 patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014. Few studies have reported the relation between hormonal levels and ectopic pregnancy (EP) in IVF. Investigators describe EP incidence according to estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) or their variation between both days.

Study Type

Observational

Enrollment (Actual)

578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014.

Description

Inclusion Criteria:

  • Normal Fallopian tubes in HSG and /or laparoscopy
  • Normal Uterus: Abscence of myomas and Müllerian anomalies .

Exclusion Criteria:

  • Previous Ectopic Pregnancy .
  • Recurrent Abortion .
  • Tubal Factor : pelvic inflammatory disease, Hydrosalpinx
  • Previous abdominal surgery (except laparoscopy) .
  • Prior Peritonitis
  • Smoking (at least 1 cigarette/day) .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First quartile
No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7).
Other: Analysis of Ectopic Pregnancy incidence
Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
Second quartile
No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7).
Other: Analysis of Ectopic Pregnancy incidence
Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
Third quartile
No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
Other: Analysis of Ectopic Pregnancy incidence
Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
Fourth quartile
No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
Other: Analysis of Ectopic Pregnancy incidence
Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ectopic pregnancy rate
Time Frame: Up to 108 months
Up to 108 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Vigo

Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (ESTIMATE)

June 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1409-VGO-059-EM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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