Bed Rest or no Bed Rest?

NCT01343992 | Completed

• 1 other identifier: 0912-C-065-SA
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

In Vitro Fertilization

Keywords

Embryo transfer; Implantation rate; Pregnancy rate; bedrest; neutral; benevolent; deterious; implantation; gestation rates

Outcome Measures

Primary Outcomes (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.

  10 months

Secondary Outcomes (6)

• Implantation rate

  2 months

• Miscarriage rate

  5 months

• Birth weight of live newborn infant after delivery

  10 months

• Birth height of live newborn infant after delivery

  10 months

• Cranial perimeter of live newborn infant after delivery

  10 months

Study Arms (2)

Bedrest

ACTIVE COMPARATOR

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

Behavioral: Bed rest

No bed rest

EXPERIMENTAL

Patients will not rest after the embryo transfer.

Behavioral: No bedrest

Interventions

Bed rest BEHAVIORAL

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

Bedrest

No bedrest BEHAVIORAL

Patients will not rest in bed after the embryo transfer.

No bed rest

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Instituto Valenciano de Infertilidad

Valencia, 46117, Spain

Location

Related Publications (1)

• 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.

  PMID: 23755954 DERIVED

MeSH Terms

Interventions

Bed Rest

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dr. Sharayi Gaikwad, MD

  Instituto Valenciano de Infertilidad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist IVI Valencia

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 28, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

ES (1)