Infertility, FemaleNCT05148624
Immediate Ambulation Versus Short-time Bed Rest in Sub-fertile Women Undergoing Embryo Transfer
A study testing embryo transfer in people with Infertility, Female, run by Dubai Fertility Center at 1 site in United Arab Emirates.
Trial summary
Bed rest after embryo transfer (ET) has been clinically advised without robust scientific evidence. In investigators' unit, post ET instructions are given immediately after ET to sub-fertile women while lying in bed. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 28 Jul 2021to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Women with known chronic endometritis
- Women with H/O recurrent >2 pregnancy loss or implantation failure
- Were enrolled in this study before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Short-time Bed Rest and Immediate Ambulation After Embryo Transfer Procedure. A Randomized Controlled Trial
Bed rest after embryo transfer (ET) has been clinically advised without robust scientific evidence. In investigators' unit, post ET instructions are given immediately after ET to sub-fertile women while lying in bed. The aim of the study is to compare the reproductive outcome of this practice compared with immediate ambulation and giving instructions after emptying the bladder.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- embryo transfer
- Keywords
- Embryo transfer, Bed rest, Clinical pregnancy, Miscarriage, Ongoing pregnancy
- Medical subject headings
- Infertility, Female, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryo transferProcedure or surgery
immediate ambulation after embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Immediate ambulation | Experimental | Sub-infertile women will immediately ambulate and empty her bladder after embryo transfer. Receives: Procedure: embryo transfer |
| short time bed rest | Active comparator | 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. Receives: Procedure: embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 10 weeks' gestation
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.
Measured: 14 weeks
Secondary outcomes (2)
Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 6 weeks' gestation
The two groups will be compared using relative risk with 95% confidence interval.
Measured: 6 weeks
Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation
The two groups will be compared using relative risk with 95% confidence interval.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start28 Jul 2021
- Primary completion20 Mar 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dubai Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elkalyoubi, Dubai Fertility Center
- Investigators
- Priya Cherian, Principal investigator, Dubai Fertility Center - Dubai Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148624
- Sponsor's protocol ID
- Bed rest after embryo transfer
- Status last verified
- Jun 2024
- First submitted
- 15 Oct 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Short-time Bed Rest and Immediate Ambulation After Embryo Transfer Procedure. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05148624
- Acronym / sponsor ID
- Bed rest after embryo transfer
- Conditions
- Infertility, Female
- Keywords
- Embryo transfer, Bed rest, Clinical pregnancy, Miscarriage, Ongoing pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Dubai Fertility CenterUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bed rest after embryo transfer (ET) has been clinically advised without robust scientific evidence. In investigators' unit, post ET instructions are given immediately after ET to sub-fertile women while lying in bed. The aim of the study is to compare the reproductive outcome of this practice compared with immediate ambulation and giving instructions after emptying the bladder.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate ambulation | Experimental | Procedure: embryo transferSub-infertile women will immediately ambulate and empty her bladder after embryo transfer. |
| short time bed rest | Active comparator | Procedure: embryo transferSub-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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embryo transferimmediate ambulation after embryo transfer | Procedure or surgery | Immediate ambulation, short time bed rest |
Primary outcome
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
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.
2 secondary outcomes
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
Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priya Cherian principal investigator
Dubai Fertility Center - Dubai Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embryo transfer in people with Infertility, Female, run by Dubai Fertility Center at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.