Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Spa Certificate) | Placebo Comparator | For every three months in the study control subjects received $50 spa gift certificates. |
|
| Mind/Body Program | Experimental | Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind/Body Program | Behavioral | Ten week group mind/body program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rates | Presence of normal fetal heart rate and fetal size at 7 weeks gestation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alice D Domar, PhD | Boston IVF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston IVF | Waltham | Massachusetts | 02451 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21496800 | Derived | Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control (Spa Certificate) | For every three months in the study control subjects received $50 spa gift certificates. Control: Spa gift certificates |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control (Spa Certificate) | For every three months in the study control subjects received $50 spa gift certificates. Control: Spa gift certificates |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Pregnancy Rates | Presence of normal fetal heart rate and fetal size at 7 weeks gestation. | Posted | Number | percentage of participants | 1 year |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (Spa Certificate) | For every three months in the study control subjects received $50 spa gift certificates. Control: Spa gift certificates |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alice D. Domar, PhD | Boston IVF | 781-434-6500 | domar@domarcenter.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control |
| Behavioral |
Spa gift certificates |
|
| 1 year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| 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. | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | 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 | 0 | 46 | 0 | 46 |
Not provided
Not provided
| Pregnancy Rate for BDI ≤ 12 at Cycle 2 |
|
|
| Pregnancy Rate for BDI ≥ 13 at Cycle 1 |
|
|
| Pregnancy Rate for BDI ≥ 13 at Cycle 2 |
|
|