Bed Rest or no Bed Rest?

April 22, 2015 updated by: Jose Remohi, Instituto Valenciano de Infertilidad, IVI VALENCIA

Evaluation of the Influence of Bed Rest After Embryo Transfer in Outcome of IVF Treatment With Ovum Donation.

A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the administration of medications are performed as always and there are no variations. The only highlighted procedure in this study is immediately after the embryo transfer. There are two groups: one which will rest in bed for 10 minutes after the transfer and one which will not rest after the transfer. Both procedures are common, usually depending on the habitual clinical practice of each clinic internationally. Patients from both group receive the routine post transfer instructions and treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46117
        • Instituto Valenciano de Infertilidad

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

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Infertile Patients with fertility problems due to tubaric or ovarian problems with normozoospermatic couple
  • Patient and her couple with ages between ages 20 - 49 years old
  • BMI < 25 kg/m2
  • IVF treatment with oocyte donation
  • Elective transfer of 2 embryos of day 3 embryos or day 5/6 embryos transferred
  • First cycle of embryo transfer

Exclusion criteria:

  • Patients with uterine abnormalities, significant uterine fibroids, Hydrosalphinx
  • History of recurrent pregnancy loss
  • severe male factor were excluded from the study

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

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bedrest
Patients will rest in bed ten minutes after the embryo transfer.
Behavioral: Bed rest
Patients will rest in bed ten minutes after the embryo transfer.
EXPERIMENTAL: No bed rest
Patients will not rest after the embryo transfer.
Behavioral: No bedrest
Patients will not rest in bed after the embryo transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth infant rate after delivery from both groups of study
Time Frame: 10 months
Whether bed rest after embryo transfer affects the pregnancy rate in IVF treatment with oocyte donation.
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate
Time Frame: 2 months
2 months
Miscarriage rate
Time Frame: 5 months
5 months
Birth weight of live newborn infant after delivery
Time Frame: 10 months
10 months
Birth height of live newborn infant after delivery
Time Frame: 10 months
10 months
Cranial perimeter of live newborn infant after delivery
Time Frame: 10 months
10 months
APGAR score of live newborn infant after delivery
Time Frame: 10 months
10 months

Collaborators and Investigators

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

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

  • Principal Investigator: Dr. Sharayi Gaikwad, MD, Instituto Valenciano de Infertilidad

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

May 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (ESTIMATE)

April 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0912-C-065-SA

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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