search
Back to results

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

Primary Purpose

Infertility, Female

Status
Recruiting
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
embryo transfer
Sponsored by
Dubai Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility, Female focused on measuring Embryo transfer, Bed rest, Clinical pregnancy, Miscarriage, Ongoing pregnancy

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dubai Fertility CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate ambulation

short time bed rest

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 15, 2021
Last Updated
April 23, 2022
Sponsor
Dubai Fertility Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05148624
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dubai Fertility Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Embryo transfer, Bed rest, Clinical pregnancy, Miscarriage, Ongoing pregnancy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate ambulation
Arm Type
Experimental
Arm Description
Sub-infertile women will immediately ambulate and empty her bladder after embryo transfer.
Arm Title
short time bed rest
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
embryo transfer
Intervention Description
immediate ambulation after embryo transfer
Primary Outcome Measure Information:
Title
Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 10 weeks' gestation
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Percentage of participants who received or did not receive bed rest after embryo transfer who carried a viable pregnancy beyond 6 weeks' gestation
Description
The two groups will be compared using relative risk with 95% confidence interval.
Time Frame
6 weeks
Title
Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation
Description
The two groups will be compared using relative risk with 95% confidence interval.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women in reproductive age group who underwent embryo transfer
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priya Cherian
Phone
0097146048770
Email
Pecherian@dha.gov.ae
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Elkalyoubi
Phone
0097146048770
Email
dr_elkalyoubi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya Cherian
Organizational Affiliation
Dubai Fertility Center - Dubai Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dubai Fertility Center
City
Dubai
ZIP/Postal Code
8729
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Elkalyoubi
Phone
00971505580045
Email
dr_elkalyoubi@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs