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

NCT05148624 | Completed DMC

• 1 other identifier: Bed rest after embryo transfer
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

Embryo transfer; Bed rest; Clinical pregnancy; Miscarriage; Ongoing pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 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

  6 weeks

• Percentage of participants who received or did not receive bed rest after embryo transfer who aborted before 12 weeks' gestation

  12 weeks

Study Arms (2)

Immediate ambulation

EXPERIMENTAL

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

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.

Procedure: embryo transfer

Interventions

embryo transfer PROCEDURE

immediate ambulation after embryo transfer

Immediate ambulation; short time bed rest

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: women in reproductive age group who underwent embryo transfer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dubai Fertility Center: lead

Study Sites (1)

Dubai Fertility Center

Dubai, 8729, United Arab Emirates

Location

MeSH Terms

Conditions

Infertility, Female; Abortion, Spontaneous

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Priya Cherian

  Dubai Fertility Center - Dubai Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obs Gyn and reproductive medicine - Head of Medical Affair

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: December 8, 2021
• Study Start: July 28, 2021
• Primary Completion: March 20, 2024
• Study Completion: June 27, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)