Immediate Ambulation Versus Short-time Bed Rest in Sub-fertile Women Undergoing Embryo Transfer
Comparative Study Between Short-time Bed Rest and Immediate Ambulation After Embryo Transfer Procedure. A Randomized Controlled Trial
Study Overview
Detailed Description
Bed rest after embryo transfers has been clinically advised without robust scientific evidence. Most of the assisted reproductive units routinely recommend a variable period of bedrest immediately after embryo transfer (ET) procedure without clear scientific evidence of its benefit. Three Randomized controlled trials (RCT) that included 712 embryo transfers with variable duration of bedrest did not report a benefit in pregnancy outcome. Only one study, however compared bedrest with no bedrest. In contrast, a 2013 RCT reported a harmful effect on the pregnancy outcome.
However, data on patients using embryos derived from their own oocytes are limited. In addition, there was no subgroup analysis to exclude confounding factors like number of oocytes retrieved and quality of embryos transferred. Few of these studies included embryos transferred after preimplantation genetic diagnosis.
The rationale behind bedrest come from the belief that decreased physical activity will help in embryo retention within the uterine cavity after replacement6. Ultrasound examination before and after ET with immediate ambulation did not show any uterine displacement of the air bubble. if gravity displaces transferred embryos, then staying with full bladder in supine position will make the anteverted ante flexed uterus more horizontal and increase the gravity effect.
Moreover, although bed rest is one of the most practiced treatments to improve reproductive outcome, most clinicians consider it the least crucial factor.
In investigators' unit, post ET instructions, which, may take up to 5 minutes, are practiced immediately after ET to patients while lying in bed. The aim of the study is to compare the effect of this practice with immediate ambulation and giving instructions after emptying the bladder in a sitting position on the reproductive outcome in patients undergoing assisted reproductive treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Dubai, United Arab Emirates, 8729
- Dubai Fertility Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Couple undergoing In vitro fertilization, Intracytoplasmic sperm injection, Frozen embryo replacement or Frozen Intracytoplasmic sperm injection
- Age between 20 to 40-year-old
- Couples who are willingly accepting to participate in the study. Both husband and wife will sign the consent.
Exclusion Criteria:
- Women with diminished ovarian reserve (AMH < 1.2 ng/ml or AFC < 7)
- Women with unilateral or bilateral hydro salpinx
- Women with bilateral endometriomas
- Women with adenomyosis
- Women with large (more than 3 cm uterine fibroid)
- Women with fluid or polyp in the uterine cavity
- Women with known chronic endometritis
- Women with H/O recurrent >2 pregnancy loss or implantation failure
- Were enrolled in this study before
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate ambulation
Sub-infertile women will immediately ambulate and empty her bladder after embryo transfer.
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immediate ambulation after embryo transfer
|
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Active Comparator: short time bed rest
Sub-infertile women will stay in the bed (same bed where embryo transfer was performed) after embryo transfer for a period of 5 minutes without emptying her bladder.
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immediate ambulation after embryo transfer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 10 weeks' gestation
Time Frame: 14 weeks
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Ongoing pregnancy will be defined as a viable pregnancy detected by ultrasound examination between 10 - 13 weeks' gestation. The two groups will be compared using relative risk with 95% confidence interval. |
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 6 weeks' gestation
Time Frame: 6 weeks
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The two groups will be compared using relative risk with 95% confidence interval.
|
6 weeks
|
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Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation
Time Frame: 12 weeks
|
The two groups will be compared using relative risk with 95% confidence interval.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Priya Cherian, Dubai Fertility Center - Dubai Health Authority
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bed rest after embryo transfer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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