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

Infertility, Female Clinical Trial

Official title:

Comparative Study Between Short-time Bed Rest and Immediate Ambulation After Embryo Transfer Procedure. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148624
• Other study ID #: Bed rest after embryo transfer
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Dubai Fertility Center
• Contact: Priya Cherian
• Phone: 0097146048770
• Email: Pecherian[@]dha.gov.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• embryo transfer
immediate ambulation after embryo transfer

Locations

Country	Name	City	State
United Arab Emirates	Dubai Fertility Center	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Dubai Fertility Center

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 weeks
Secondary	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.	6 weeks
Secondary	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.	12 weeks