The Impact of Distress on the IVF Outcome

Boston IVF

Status: Completed

Conditions: Infertility

Treatments: Behavioral: Mind/Body Program; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01103973

20070076

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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143 participants in 2 patient groups, including a placebo group

Control (Spa Certificate)

Placebo Comparator group

Description:

For every three months in the study control subjects received $50 spa gift certificates.

Treatment:

Behavioral: Control

Mind/Body Program

Experimental group

Description:

Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.

Treatment:

Behavioral: Mind/Body Program