Bed Rest or no Bed Rest?

Study Overview
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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.

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

Conditions
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In Vitro Fertilization

Intervention / Treatment
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* Behavioral: Bed rest
* Behavioral: No bedrest


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bedrest<br>Patients will rest in bed ten minutes after the embryo transfer. | Behavioral: Bed rest<br>* Patients will rest in bed ten minutes after the embryo transfer.<br>|
| Experimental: No bed rest<br>Patients will not rest after the embryo transfer. | Behavioral: No bedrest<br>* Patients will not rest in bed after the embryo transfer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embryo transfer, Implantation rate, Pregnancy rate, bedrest, neutral, benevolent, deterious, implantation, gestation rates