Infertility
Conditions
Keywords
IVF, Mind/Body
Brief 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.
Interventions
BEHAVIORALMind/Body Program
Ten week group mind/body program
BEHAVIORALControl
Spa gift certificates
Sponsors
Boston IVF
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rates | 1 year | Presence of normal fetal heart rate and fetal size at 7 weeks gestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Control (Spa Certificate) For every three months in the study control subjects received $50 spa gift certificates.
Control: Spa gift certificates | 51 |
| 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 | 46 |
| Total | 97 |
Baseline characteristics
| Characteristic | Control (Spa Certificate) | Mind/Body Program | Total |
|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 3.8 | 34 years STANDARD_DEVIATION 3.7 | 34 years STANDARD_DEVIATION 3.75 |
| Sex: Female, Male Female | 51 Participants | 46 Participants | 97 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 46 |
| serious Total, serious adverse events | 0 / 51 | 0 / 46 |
Outcome results
Primary
Clinical Pregnancy Rates
Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (Spa Certificate) | Clinical Pregnancy Rates | 20 percentage of participants |
| Mind/Body Program | Clinical Pregnancy Rates | 52 percentage of participants |
Secondary
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (Spa Certificate) | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≥ 12 at Cycle 1 | 15 Participants |
| Control (Spa Certificate) | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≤ 12 at Cycle 2 | 4 Participants |
| Control (Spa Certificate) | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≥ 13 at Cycle 1 | 7 Participants |
| Control (Spa Certificate) | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≥ 13 at Cycle 2 | 0 Participants |
| Mind/Body Program | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≥ 13 at Cycle 2 | 2 Participants |
| Mind/Body Program | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≥ 12 at Cycle 1 | 12 Participants |
| Mind/Body Program | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≥ 13 at Cycle 1 | 8 Participants |
| Mind/Body Program | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Pregnancy Rate for BDI ≤ 12 at Cycle 2 | 9 Participants |