Trial Outcomes & Findings for Coping Intervention After Embryo Transfer (NCT NCT01701011)

Results Overview

The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

377 participants

Primary outcome timeframe

T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer

Results posted on

2016-08-10

Participant Flow

In the 20 months of recruitment, between October 2010 and June 2012, 1445 letters were sent to women with an invitation to the trial.

Of the 565 women who replied via a letter or email, 188 (33%) were not eligible. The remaining 377 women were randomised and the 349 who had an embryo to transfer (n=119 PRCI-monitoring, n=117 monitoring-control, n=113 routine care control)

Participant milestones

Participant milestones
Measure	PRCI-monitoring Group Coping intervention, Daily Record Keeping, Questionnaires	Monitoring-control Group Daily Record Keeping and Questionnaires	Routine Care Control Group Patients receive only questionnaires
Overall Study STARTED	127	126	124
Overall Study COMPLETED	92	102	90
Overall Study NOT COMPLETED	35	24	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coping Intervention After Embryo Transfer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRCI-monitoring Group n=127 Participants Coping intervention, Daily Record Keeping, Questionnaires Coping intervention, Daily Record Keeping, Questionnaires :	Monitoring-control Group n=126 Participants DRK and Questionnaires Coping intervention, Daily Record Keeping, Questionnaires :	Routine Care Control Group n=124 Participants Questionnaires Coping intervention, Daily Record Keeping, Questionnaires :	Total n=377 Participants Total of all reporting groups
Age, Continuous	34.9 years STANDARD_DEVIATION 4.7 • n=5 Participants	34.6 years STANDARD_DEVIATION 4.7 • n=7 Participants	34.8 years STANDARD_DEVIATION 5.0 • n=5 Participants	34.8 years STANDARD_DEVIATION 4.8 • n=4 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	126 Participants n=7 Participants	124 Participants n=5 Participants	377 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Netherlands	127 participants n=5 Participants	126 participants n=7 Participants	124 participants n=5 Participants	377 participants n=4 Participants

PRIMARY outcome

Timeframe: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer

Population: Only in women with embryo transfer

The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.

Outcome measures

Outcome measures
Measure	PRCI-monitoring Group n=119 Participants Coping intervention, Daily Record Keeping, Questionnaires	Monitoring-control Group n=117 Participants Daily Record Keeping and Questionnaires	Routine Care Control Group n=113 Participants patients receive questionnaires
Anxiety Time 1	6.279 units on a scale Standard Error 0.242	6.223 units on a scale Standard Error 0.243	6.095 units on a scale Standard Error 0.251
Anxiety Time 2	7.302 units on a scale Standard Error 0.269	7.526 units on a scale Standard Error 0.249	8.175 units on a scale Standard Error 0.272
Anxiety Time 3	5.798 units on a scale Standard Error 0.279	5.571 units on a scale Standard Error 0.262	6.317 units on a scale Standard Error 0.288

SECONDARY outcome

Timeframe: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer

Population: Only in women with embryo transfer

The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.

Outcome measures

Outcome measures
Measure	PRCI-monitoring Group n=119 Participants Coping intervention, Daily Record Keeping, Questionnaires	Monitoring-control Group n=117 Participants Daily Record Keeping and Questionnaires	Routine Care Control Group n=113 Participants patients receive questionnaires
Depression Time 1	3.389 units on a scale Standard Error 0.199	3.391 units on a scale Standard Error 0.201	3.269 units on a scale Standard Error 0.208
Depression Time 2	3.709 units on a scale Standard Error 0.222	3.676 units on a scale Standard Error 0.206	4.224 units on a scale Standard Error 0.225
Depression Time 3	3.983 units on a scale Standard Error 0.230	3.708 units on a scale Standard Error 0.216	3.736 units on a scale Standard Error 0.238

Adverse Events

PRCI-monitoring Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Monitoring-control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Routine Care Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Henrietta Ockhuijsen 1,*, Agnes van den Hoogen, Marinus Eijkemans , Nick Macklon, Jacky Boivin

UMCU

Phone: +31307553628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place