Bed Rest or no Bed Rest?

In Vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343992
• Other study ID #: 0912-C-065-SA
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: April 22, 2015
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2015
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Behavioral:
• Bed rest
Patients will rest in bed ten minutes after the embryo transfer.
• No bedrest
Patients will not rest in bed after the embryo transfer.

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Implantation rate		2 months	No
Secondary	Miscarriage rate		5 months	No
Secondary	Birth weight of live newborn infant after delivery		10 months	No
Secondary	Birth height of live newborn infant after delivery		10 months	No
Secondary	Cranial perimeter of live newborn infant after delivery		10 months	No
Secondary	APGAR score of live newborn infant after delivery		10 months	No