Trial Outcomes & Findings for The Impact of Distress on the IVF Outcome (NCT NCT01103973)
NCT ID: NCT01103973
Last Updated: 2018-01-18
Results Overview
Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
COMPLETED
NA
143 participants
1 year
2018-01-18
Participant Flow
A total of 46 women withdrew or were ineligible for the study. The reasons for withdrawal were: 1) no longer eligible owing to no subsequent IVF cycle (15 patients); 2) too great a time commitment (15 patients); 3) noncompliance with study requirements (7 patients); 4) dislike of study tasks (6 patients); and 5) other (3 patients).
Participant milestones
| Measure |
Control (Spa Certificate)
For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates
|
Mind/Body Program
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
46
|
|
Overall Study
COMPLETED
|
51
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Distress on the IVF Outcome
Baseline characteristics by cohort
| Measure |
Control (Spa Certificate)
n=51 Participants
For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates
|
Mind/Body Program
n=46 Participants
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
34 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
34 years
STANDARD_DEVIATION 3.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPresence of normal fetal heart rate and fetal size at 7 weeks gestation.
Outcome measures
| Measure |
Control (Spa Certificate)
n=51 Participants
For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates
|
Mind/Body Program
n=46 Participants
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program
|
|---|---|---|
|
Clinical Pregnancy Rates
|
20 percentage of participants
|
52 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Subjects were evaluated before IVF cycle 1 and cycle 2 if applicable. The N varies per cycle as some patients withdrew from the study or did not have a second cycle.
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.
Outcome measures
| Measure |
Control (Spa Certificate)
n=51 Participants
For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates
|
Mind/Body Program
n=46 Participants
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Mind/Body Program: Ten week group mind/body program
|
|---|---|---|
|
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
Pregnancy Rate for BDI ≥ 12 at Cycle 1
|
15 Participants
|
12 Participants
|
|
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
Pregnancy Rate for BDI ≤ 12 at Cycle 2
|
4 Participants
|
9 Participants
|
|
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
Pregnancy Rate for BDI ≥ 13 at Cycle 1
|
7 Participants
|
8 Participants
|
|
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
Pregnancy Rate for BDI ≥ 13 at Cycle 2
|
0 Participants
|
2 Participants
|
Adverse Events
Control (Spa Certificate)
Mind/Body Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place