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NCT Number: NCT01103973

The Impact of Distress on the IVF Outcome

Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (ART) patients. The objective of this study is to determine if women who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will have higher pregnancy rates than controls (C).

This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first IVF cycle. Subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two IVF cycles. The primary outcome measure is clinical pregnancy rate.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston IVF

Waltham, Massachusetts, 02451, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female Boston IVF infertility patient
  • Age 21-40 years
  • Day 3 FSH level 12 mIU/ml or below
  • Day 3 E2 level 80 pg/ml or below
  • Using own eggs (not an egg donor)
  • Daily access to the internet
  • Able to read, understand, and sign the informed consent in English

Exclusion criteria

  • Prescription antipsychotic medication
  • Diagnosis of borderline or narcissistic personality disorder
  • Previous participation in a MB group

Treatment and study plan

Mind/Body Program

Behavioral

Ten week group mind/body program

Control

Behavioral

Spa gift certificates

Primary outcomes

  1. Clinical Pregnancy Rates

    Time frame: 1 year

    Presence of normal fetal heart rate and fetal size at 7 weeks gestation.

Secondary outcomes

  1. Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)

    Time frame: 1 year

    Psychological status is assessed by the Beck Depression Inventory (BDI). The scores range from 0 to 63; a score of 0 being no depression and 63 being severely depressed. Our cut-off for normal was a score of 12 or less, and those with a score of 13 or greater were considered to have symptoms of depression.

Sponsors and collaborators

Lead sponsor

Boston IVF

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2010
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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