N/A
N=97
The Impact of Distress on the IVF Outcome
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01103973 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Clinical Pregnancy Rates — 20; 52 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mind/Body Program (Behavioral); Control (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Boston IVF
- Primary completion
- Sep 2009
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 | — |
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.
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
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.