Immediate Ambulation Versus Short-time Bed Rest in Sub-fertile Women Undergoing Embryo Transfer

NCT ID: NCT05148624

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2024-06-27

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Immediate ambulation

Sub-infertile women will immediately ambulate and empty her bladder after embryo transfer.

Group Type: EXPERIMENTAL

embryo transfer

Intervention Type: PROCEDURE

immediate ambulation after embryo transfer

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.

Group Type: ACTIVE_COMPARATOR

embryo transfer

Intervention Type: PROCEDURE

immediate ambulation after embryo transfer

Interventions

embryo transfer

immediate ambulation after embryo transfer

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dubai Fertility Center

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elkalyoubi

Consultant Obs Gyn and reproductive medicine - Head of Medical Affair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priya Cherian

Role: PRINCIPAL_INVESTIGATOR

Dubai Fertility Center - Dubai Health Authority

Locations

Dubai Fertility Center

Dubai, , United Arab Emirates

Countries

United Arab Emirates

Other Identifiers

Bed rest after embryo transfer

Identifier Type: -

Identifier Source: org_study_id