Infertility/SterilityPACINCT03118219
Positive Adjustment Coping Intervention
A study testing Positive adjustment coping intervention and Brainteaser in people with Infertility/Sterility, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility/Sterility
- What is being tested?
- Positive adjustment coping intervention and Brainteaser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2017to 8 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have
- agreed to participate in the study
- indicated their mobile phone number
- sufficient knowledge of German language.
- If one partner is refusing to participate, the other person may be admitted as an individual.
Who cannot join
- denial of participation
- non-existent smartphone
- insufficient knowledge of German language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.
Read the detailed description
About 8% of all couples of reproductive age are involuntary childless, and just about 25,000 couples receive a medical treatment each year in Germany, which is experienced as "roller coaster of emotions". The positive effect of "face-to-face" counseling for couples with a desire for children has been proven. However, this does not yet apply to a variety of other forms of intervention, e.g. telephone or online counseling.
In this study, the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design.
For this purpose, an intervention group and a comparison intervention group of each n = 60 couples in reproductive treatment will be examined at two points during a four-week interval using the ScreenIVF questionaire. The ScreenIVF will be completed paper-pencil before the intervention and online after the intervention. In the fourteen-day waiting period between oocyte puncture and pregnancy test (or the reappearance of menstruation), both groups receive either positive adjustment techniques or brainteasers.In addition, both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques.
Sociodemographic variables (such as age, education) and medical data (such as diagnosis, previous treatment cycles) as potential moderators, as well as possible pregnancies at the second measurement time will be reported.
No adverse effects or other risks are expected for the study participants.
- Conditions
- Infertility/Sterility
- Being tested
- Positive adjustment coping intervention, Brainteaser
- Keywords
- assisted reproductive technology, embryo transfer, online intervention, rct
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive adjustment coping interventionOther
see arm description
BrainteaserOther
Also called Comparison intervention group
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Positive adjustment coping intervention | Experimental | All persons allocated to the intervention group will receive daily text messages (SMS) to their smartphones with sentences for positive adjustment over two weeks starting from the day of the egg-cell punctuation. Receives: Other: Positive adjustment coping intervention |
| Brainteaser | Other | All persons allocated to the comparison intervention group will receive daily text messages (SMS) to their smartphones with brainteasers over two weeks starting from the day of the egg-cell punctuation. Receives: Other: Brainteaser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the Screen IVF questionaire between the intervention groups
Differences in the ScreenIVF risk profile at post-measurement time between the intervention group of positive adjustment and the intervention comparison group with the brainteasers
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
Quantitative evaluation of participants' opinion about the intervention
Participants will be questioned about the perceived effectiveness and practicability of the intervention techniques with quantitative items (Rating scales).
Measured: through study completion, an average of 2 years
Qualitative evaluation of participants' opinion about the intervention
Participants will be questioned about the recommendations to others concerning the intervention techniques (open questions)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start18 Jul 2017
- Primary completion12 Jun 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility/SterilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maren Schick, University Hospital Heidelberg
- Investigators
- Tewes Wischmann, PD Dr., Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118219
- Sponsor's protocol ID
- S-074/2017
- Acronym
- PACI
- Status last verified
- Sep 2019
- First submitted
- 29 Mar 2017
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lancastle D, Boivin J. A feasibility study of a brief coping intervention (PRCI) for the waiting period before a pregnancy test during fertility treatment. Hum Reprod. 2008 Oct;23(10):2299-307. doi: 10.1093/humrep/den257. Epub 2008 Jul 15.
PubMed 18628259Kremer F, Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: A randomised controlled trial. PLoS One. 2025 Dec 8;20(12):e0335776. doi: 10.1371/journal.pone.0335776. eCollection 2025.
PubMed 41359611Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
PubMed 32779730Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol. BMJ Open. 2019 Jul 9;9(7):e025288. doi: 10.1136/bmjopen-2018-025288.
PubMed 31289056
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
- ClinicalTrials.gov ID
- NCT03118219
- Acronym / sponsor ID
- PACI / S-074/2017
- Conditions
- Infertility/Sterility
- Keywords
- assisted reproductive technology, embryo transfer, online intervention, rct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.
Detailed description
About 8% of all couples of reproductive age are involuntary childless, and just about 25,000 couples receive a medical treatment each year in Germany, which is experienced as "roller coaster of emotions". The positive effect of "face-to-face" counseling for couples with a desire for children has been proven. However, this does not yet apply to a variety of other forms of intervention, e.g. telephone or online counseling.
In this study, the effectiveness of a smartphone-supported psychosocial intervention for women and men in reproductive treatment will be examined in a randomized controlled pre-post design.
For this purpose, an intervention group and a comparison intervention group of each n = 60 couples in reproductive treatment will be examined at two points during a four-week interval using the ScreenIVF questionaire. The ScreenIVF will be completed paper-pencil before the intervention and online after the intervention. In the fourteen-day waiting period between oocyte puncture and pregnancy test (or the reappearance of menstruation), both groups receive either positive adjustment techniques or brainteasers.In addition, both groups are questioned one month after the post-measurement date on the perceived effectiveness and practicability of the intervention techniques.
Sociodemographic variables (such as age, education) and medical data (such as diagnosis, previous treatment cycles) as potential moderators, as well as possible pregnancies at the second measurement time will be reported.
No adverse effects or other risks are expected for the study participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive adjustment coping intervention | Experimental | Other: Positive adjustment coping interventionAll persons allocated to the intervention group will receive daily text messages (SMS) to their smartphones with sentences for positive adjustment over two weeks starting from the day of the egg-cell punctuation. |
| Brainteaser | Other | Other: BrainteaserAll persons allocated to the comparison intervention group will receive daily text messages (SMS) to their smartphones with brainteasers over two weeks starting from the day of the egg-cell punctuation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have
- agreed to participate in the study
- indicated their mobile phone number
- sufficient knowledge of German language.
- If one partner is refusing to participate, the other person may be admitted as an individual.
Key exclusion criteria (3 listed)
- denial of participation
- non-existent smartphone
- insufficient knowledge of German language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive adjustment coping interventionsee arm description | Other | Positive adjustment coping intervention |
| BrainteaserAlso: Comparison intervention groupsee arm description | Other | Brainteaser |
Primary outcome
Differences in the Screen IVF questionaire between the intervention groups
Time frame: through study completion, an average of 2 years
Differences in the ScreenIVF risk profile at post-measurement time between the intervention group of positive adjustment and the intervention comparison group with the brainteasers
2 secondary outcomes
Quantitative evaluation of participants' opinion about the intervention
Time frame: through study completion, an average of 2 years
Qualitative evaluation of participants' opinion about the intervention
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Background: PubMed 18628259Lancastle D, Boivin J. A feasibility study of a brief coping intervention (PRCI) for the waiting period before a pregnancy test during fertility treatment. Hum Reprod. 2008 Oct;23(10):2299-307. doi: 10.1093/humrep/den257. Epub 2008 Jul 15.
- Derived from this study: PubMed 41359611Kremer F, Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: A randomised controlled trial. PLoS One. 2025 Dec 8;20(12):e0335776. doi: 10.1371/journal.pone.0335776. eCollection 2025.
- Derived from this study: PubMed 32779730Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- Derived from this study: PubMed 31289056Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol. BMJ Open. 2019 Jul 9;9(7):e025288. doi: 10.1136/bmjopen-2018-025288.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tewes Wischmann, PD Dr. study director
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive adjustment coping intervention and Brainteaser in people with Infertility/Sterility, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the Screen IVF questionaire between the intervention groups (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118219, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.