Bed Rest or no Bed Rest?

NCT ID: NCT01343992

Last Updated: 2015-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bedrest

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

Group Type ACTIVE_COMPARATOR

Bed rest

Intervention Type BEHAVIORAL

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

No bed rest

Patients will not rest after the embryo transfer.

Group Type EXPERIMENTAL

No bedrest

Intervention Type BEHAVIORAL

Patients will not rest in bed after the embryo transfer.

Interventions

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Bed rest

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

Intervention Type BEHAVIORAL

No bedrest

Patients will not rest in bed after the embryo transfer.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Jose Remohi

Gynecologist IVI Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Sharayi Gaikwad, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Valenciano de Infertilidad

Locations

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Instituto Valenciano de Infertilidad

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 23755954 (View on PubMed)

Other Identifiers

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0912-C-065-SA

Identifier Type: -

Identifier Source: org_study_id

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