Impact of Physician Contact on Patient Anxiety During the Waiting Period After Embryo Transfer

NCT04190732 | Unknown

• 1 other identifier: 2019P000939
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized controlled trial to compare if physician contact within the period from embryo transfer to serum pregnancy test decreases anxiety levels for first-time IVF patients.

Conditions

Infertility

Keywords

infertility; in-vitro fertilization (IVF); anxiety; distress

Outcome Measures

Primary Outcomes (1)

• Change in anxiety levels from two time points in an IVF cycle measured by the State Trait Anxiety Inventory - State (STAI-S) survey

  The investigators will assess change in anxiety levels from T1 to T2 using the State Trait Anxiety Inventory - State survey. A lower score on the State Trait Anxiety Inventory - State at T2 signifies a decrease in anxiety levels for a participant. The minimum and maximum score on the State Trait Anxiety Inventory - State is 20 and 80.

  Completed twice: once between IVF stimulation days 1-4 (T1) and again 8 days after (T2) embryo transfer and before first pregnancy test

Study Arms (2)

Physician phone call

EXPERIMENTAL

Participants will receive a five-minute phone call from one physician 3 to 4 days after a fresh or frozen embryo transfer. The physician will not have access to patient specific IVF cycle details. The phone call will follow scripted questions and utilize scripted phrases to help minimize variation.

Behavioral: Physician phone call

Routine care

NO INTERVENTION

Participants will receive routine care and no physician phone call will be performed during the waiting period between embryo transfer and the pregnancy test.

Interventions

Physician phone call BEHAVIORAL

Often, patients will not have contact with a physician during the waiting period between embryo transfer and the pregnancy test. Participants in the intervention group will receive a phone call from one physician 3 to 4 days after fresh or frozen embryo transfer to check in. The physician will introduce themselves and state they are a part of the research team.

Physician phone call

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Female patients undergoing In vitro fertilization treatment using their own eggs
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• First IVF cycle
• Autologous cycle
• years of age

You may not qualify if:

• Utilizing a gestational carrier
• Preimplantation Genetic Testing for chromosome structural rearrangements (PGT- SR)
• Preimplantation Genetic Testing for Single gene (monogenic) (PGT-M)

Sponsors & Collaborators

• Boston IVF: lead

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Infertility; Anxiety Disorders

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mental Disorders

Study Officials

• Alan Penzias, MD

  Boston IVF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 9, 2019
• Study Start: January 6, 2020
• Primary Completion: January 6, 2021
• Study Completion: June 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)