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In Vitro FertilizationNCT01343992

Bed Rest or no Bed Rest?

A study testing Bed rest and No bedrest in people with In Vitro Fertilization, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
In Vitro Fertilization
What is being tested?
Bed rest and No bedrest
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteSpain
Study dates
May 2011to Nov 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Instituto Valenciano de Infertilidad

    Valencia, 46117

Other trials in Spain

About this study

Official title: 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.

Being tested
Bed rest, No bedrest
Keywords
Embryo transfer, Implantation rate, Pregnancy rate, bedrest, neutral, benevolent, deterious, implantation, gestation rates

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bed restBehavioural

    Patients will rest in bed ten minutes after the embryo transfer.

  • No bedrestBehavioural

    Patients will not rest in bed after the embryo transfer.

Study groups in NCT01343992
Study groupRoleWhat they receive
BedrestActive comparatorPatients will rest in bed ten minutes after the embryo transfer.
Receives: Behavioral: Bed rest
No bed restExperimentalPatients will not rest after the embryo transfer.
Receives: Behavioral: No bedrest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth infant rate after delivery from both groups of study

    Whether bed rest after embryo transfer affects the pregnancy rate in IVF treatment with oocyte donation.

    Measured: 10 months

Secondary outcomes (6)

  1. Implantation rate

    Measured: 2 months

  2. Miscarriage rate

    Measured: 5 months

  3. Birth weight of live newborn infant after delivery

    Measured: 10 months

  4. Birth height of live newborn infant after delivery

    Measured: 10 months

  5. Cranial perimeter of live newborn infant after delivery

    Measured: 10 months

  6. APGAR score of live newborn infant after delivery

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01343992
Sponsor's protocol ID
0912-C-065-SA
Status last verified
Apr 2015
First submitted
27 Apr 2011
Last updated
23 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Gaikwad S, Garrido N, Cobo A, Pellicer A, Remohi J. Bed rest after embryo transfer negatively affects in vitro fertilization: a randomized controlled clinical trial. Fertil Steril. 2013 Sep;100(3):729-35. doi: 10.1016/j.fertnstert.2013.05.011. Epub 2013 Jun 10.

    PubMed 23755954

Questions about this trial

What is this clinical trial studying?

A study testing Bed rest and No bedrest in people with In Vitro Fertilization, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth infant rate after delivery from both groups of study (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01343992, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.

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