Bed Rest or no Bed Rest?

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)

Overall Status

Completed

CT.gov ID

NCT01343992

Collaborator

(none)

240

Enrollment

Location

Arms

Duration (Months)

39.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
In Vitro Fertilization	Behavioral: Bed rest Behavioral: No bedrest	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Live birth infant rate after delivery from both groups of study [10 months]
Whether bed rest after embryo transfer affects the pregnancy rate in IVF treatment with oocyte donation.

Secondary Outcome Measures

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]
APGAR score of live newborn infant after delivery [10 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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