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Bed Rest or no Bed Rest?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sharayu Gaikwad, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01343992
First received: April 27, 2011
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
In Vitro Fertilization
 Behavioral: Bed rest
Behavioral: No bedrest

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of the Influence of Bed Rest After Embryo Transfer in Outcome of IVF Treatment With Ovum Donation.

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Live birth infant rate after delivery from both groups of study [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Whether bed rest after embryo transfer affects the pregnancy rate in IVF treatment with oocyte donation.


Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Miscarriage rate [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Birth weight of live newborn infant after delivery [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Birth height of live newborn infant after delivery [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Cranial perimeter of live newborn infant after delivery [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • APGAR score of live newborn infant after delivery [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343992

Locations
Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46117
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Dr. Sharayi Gaikwad, MD Instituto Valenciano de Infertilidad
  More Information

No publications provided

Responsible Party: Sharayu Gaikwad, Gynecologist IVI Valencia, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01343992     History of Changes
Other Study ID Numbers: 0912-C-065-SA
Study First Received: April 27, 2011
Last Updated: December 13, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Embryo transfer
Implantation rate
Pregnancy rate
bedrest
neutral
 benevolent
deterious
implantation
gestation rates

ClinicalTrials.gov processed this record on May 23, 2013