Clinical trial NCT05148624: Immediate Ambulation Versus Short-time Bed Rest in Sub-fertile Women Undergoing Embryo Transfer
Official title: Comparative Study Between Short-time Bed Rest and Immediate Ambulation After Embryo Transfer Procedure. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: Embryo transfer
Bed rest
Clinical pregnancy
Miscarriage
Ongoing pregnancy
Lead sponsor: Dubai Fertility Center
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 156
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 10 weeks' gestation
timeFrame: 14 weeks
Secondary outcomes:
measure: Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 6 weeks' gestation
timeFrame: 6 weeks
measure: Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Dubai Fertility Center
Study officials:
affiliation: Dubai Fertility Center - Dubai Health Authority
name: Priya Cherian
role: PRINCIPAL_INVESTIGATOR
References: