N/A Completed N=97 Randomized Treatment

The Impact of Distress on the IVF Outcome

Infertility

Source: ClinicalTrials.gov NCT01103973 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcomePrimary: Clinical Pregnancy Rates — 20; 52 percentage of participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Pregnancy Rates	20; 52	—
SECONDARY Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)	15; 12; 4; 9; 7; 8	—

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01103973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.