Quality of LifeNCT04048772
CALM IVF (Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients)
A study testing CALM IVF in people with Quality of Life and IVF, run by University of Iowa at 1 site in United States.
Trial summary
The investigators have designed a psychoeducational group curriculum specifically for new in vitro fertilization (IVF) patients (both male and female) to improve their treatment knowledge, to allow them to engage more in their care, to offer a support network, to improve satisfaction, and to provide them with tools to… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, IVF, Patient Satisfaction
- What is being tested?
- CALM IVF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 26 Oct 2021
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients starting their first in vitro fertilization cycle at the University of Iowa Hospitals and Clinics
Who cannot join
- Patients who have already undergone in vitro fertilization treatment at any institution
- Non-English speakers
- Fertility preservation patients
- Patients using donor oocytes, embryos, or sperm
- Patients taking psychotropic medications for depression or anxiety that have had a dosing adjustment within 3 months of study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients
The investigators have designed a psychoeducational group curriculum specifically for new in vitro fertilization (IVF) patients (both male and female) to improve their treatment knowledge, to allow them to engage more in their care, to offer a support network, to improve satisfaction, and to provide them with tools to help reduce their stress and anxiety while undergoing the IVF process. The investigators plan to have four to eight infertility patients and their partners participate in a group at a time, for which they will attend three 1-1.5 hour interactive sessions that are scheduled throughout their first IVF cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques. They will do several surveys before and after the intervention for comparison, including assessment of quality of life, depression, anxiety, resilience, and a knowledge assessment. The investigators will also track the patients to see if they pursue additional treatment in the instance of a negative pregnancy test compared to patients undergoing the standard treatment. The investigators plan to recruit a control group that receives the standard of care treatment here at the University of Iowa.
Read the detailed description
Patients and their partners (if present and consenting) will be randomized in a 2:1 fashion to two different treatment arms: A) standard of care in vitro fertilization (IVF) at the investigational institution as well as participating in an additional psychoeducational group or B) standard of care IVF at the investigational institution. The intervention group will consist of three additional evening visits for 1-1.5 hours per session. The sessions will include an interactive educational component addressing usual questions and concerns of IVF patients, such as reviewing common IVF myths, and also more information regarding treatment and technologies. Each session will also include teaching of coping strategies (such as awaiting the pregnancy test, how to cope with insensitive remarks from friends and family) as well as relaxation exercises, such as progressive muscle relaxation and deep breathing.
The patients will be consented at their new IVF visit and will take their initial assessments (FertiQoL, GAD-7, PHQ-9, the Connor-Davidson Resilience Scale, and a knowledge assessment) within 24 hours of the new visit. The patients will be assigned into groups based on when they are going through their IVF stimulations, so they will have similar experiences at similar times. Patients will take their final assessments on the third day after egg retrieval, regardless of group assignment.
When partners are present and consent to the study, they will be treated as a dyad with the patient undergoing oocyte retrieval. Some patients go through treatment alone (i.e. single adults desiring pregnancy) and therefore may not have a partner available to participate. Partners level of involvement in a cycle may very, as may their desire to participate in a psychosocial intervention. As patients and their partners make joint decisions throughout their IVF cycle and the cycle itself has a single outcome, we enrolled partners as dyads with patients when partners were present, but did not require a partner to enroll a patient.
- Being tested
- CALM IVF, Standard of Care
- Keywords
- Relaxation, Education, Support, Group, Knowledge, Therapy, In vitro fertilization, Stress, Relationships, IVF
- Medical subject headings
- Patient Satisfaction, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALM IVFBehavioural
The intervention will be three 1-1.5 hour interactive sessions that are scheduled throughout the participant's first in vitro fertilization cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques.
Standard of CareOther
Patients will receive the standard of care IVF treatment at the University of Iowa.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Standard of care in vitro fertilization patients randomized to the psychoeducational group intervention. Receives: Behavioral: CALM IVF |
| Control | Other | Standard of care in vitro fertilization patients at our institution. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in female fertility patient quality of life score during IVF treatment cycle
FertiQoL International (Fertility Quality of Life Questionnaire 2008), scored scale from 0-100, with higher values indicating a higher quality of life and low scores indicating a lower quality of life.
Measured: From enrollment to 2-4 days after oocyte retrieval
Secondary outcomes (10)
Change in female GAD-7 score during IVF treatment cycle
Generalized Anxiety Disorder 7-item scale, with higher scores indicating higher likelihood of an anxiety disorder and lower scores indicating less likelihood of an anxiety disorder.
Measured: From enrollment to 2-4 days after oocyte retrieval
Change in female PHQ-9 score during IVF treatment cycle
Patient Health Questionnaire, with higher score indicating increased likelihood of a depressive disorder and lower scores indicating less likelihood of a depressive disorder.
Measured: From enrollment to 2-4 days after oocyte retrieval
Change in female Connor-Davidson Resilience Scale during IVF treatment cycle
Connor-Davidson Resilience Scale, with higher scores indicating greater resilience, and lower scores indicating lower resilience
Measured: From enrollment to 2-4 days after oocyte retrieval
Change in female knowledge assessment during IVF treatment cycle
Assessment of knowledge regarding IVF treatment, with higher scores indicating a greater knowledge of IVF treatment, and lower scores indicating less knowledge regarding IVF treatment
Measured: From enrollment to 2-4 days after oocyte retrieval
Likelihood of continued IVF treatment in the instance of a negative pregnancy test
Patients who are not pregnant after embryo transfer will be followed for three months to assess likelihood to return for additional treatment after negative embryo transfer outcome.
Measured: Three months after embryo transfer
Change in male fertility patient quality of life score during IVF treatment cycle
FertiQoL International (Fertility Quality of Life Questionnaire 2008), scored scale from 0-100, with higher values indicating a higher quality of life and low scores indicating a lower quality of life.
Measured: From enrollment to 2-4 days after oocyte retrieval
Change in male GAD-7 score during IVF treatment cycle
Generalized Anxiety Disorder 7-item scale, with higher scores indicating higher likelihood of an anxiety disorder and lower scores indicating less likelihood of an anxiety disorder.
Measured: From enrollment to 2-4 days after oocyte retrieval
Change in male PHQ-9 score during IVF treatment cycle
Patient Health Questionnaire, with higher score indicating increased likelihood of a depressive disorder and lower scores indicating less likelihood of a depressive disorder.
Measured: From enrollment to 2-4 days after oocyte retrieval
Change in male Connor-Davidson Resilience Scale during IVF treatment cycle
Connor-Davidson Resilience Scale, with higher scores indicating greater resilience, and lower scores indicating lower resilience
Measured: From enrollment to 2-4 days after oocyte retrieval
Change in male knowledge assessment during IVF treatment cycle
Assessment of knowledge regarding IVF treatment, with higher scores indicating a greater knowledge of IVF treatment, and lower scores indicating less knowledge regarding IVF treatment
Measured: From enrollment to 2-4 days after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start9 Aug 2019
- Primary completion9 Aug 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel M Whynott, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048772
- Sponsor's protocol ID
- 201906788
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2019
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whynott RM, Summers KM, Mejia RB, Segre LS, Ryan G, Pawlak SA. Creating affiliations, learning, and mindfulness for in vitro fertilization patients (CALM IVF): a clinical trial. F S Rep. 2023 Jan 7;4(1):61-71. doi: 10.1016/j.xfre.2023.01.002. eCollection 2023 Mar.
PubMed 36959953
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients
- ClinicalTrials.gov ID
- NCT04048772
- Acronym / sponsor ID
- 201906788
- Keywords
- Relaxation, Education, Support, Group, Knowledge, Therapy, In vitro fertilization, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 7 Aug 2019 (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.
The investigators have designed a psychoeducational group curriculum specifically for new in vitro fertilization (IVF) patients (both male and female) to improve their treatment knowledge, to allow them to engage more in their care, to offer a support network, to improve satisfaction, and to provide them with tools to help reduce their stress and anxiety while undergoing the IVF process. The investigators plan to have four to eight infertility patients and their partners participate in a group at a time, for which they will attend three 1-1.5 hour interactive sessions that are scheduled throughout their first IVF cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques. They will do several surveys before and after the intervention for comparison, including assessment of quality of life, depression, anxiety, resilience, and a knowledge assessment. The investigators will also track the patients to see if they pursue additional treatment in the instance of a negative pregnancy test compared to patients undergoing the standard treatment. The investigators plan to recruit a control group that receives the standard of care treatment here at the University of Iowa.
Detailed description
Patients and their partners (if present and consenting) will be randomized in a 2:1 fashion to two different treatment arms: A) standard of care in vitro fertilization (IVF) at the investigational institution as well as participating in an additional psychoeducational group or B) standard of care IVF at the investigational institution. The intervention group will consist of three additional evening visits for 1-1.5 hours per session. The sessions will include an interactive educational component addressing usual questions and concerns of IVF patients, such as reviewing common IVF myths, and also more information regarding treatment and technologies. Each session will also include teaching of coping strategies (such as awaiting the pregnancy test, how to cope with insensitive remarks from friends and family) as well as relaxation exercises, such as progressive muscle relaxation and deep breathing.
The patients will be consented at their new IVF visit and will take their initial assessments (FertiQoL, GAD-7, PHQ-9, the Connor-Davidson Resilience Scale, and a knowledge assessment) within 24 hours of the new visit. The patients will be assigned into groups based on when they are going through their IVF stimulations, so they will have similar experiences at similar times. Patients will take their final assessments on the third day after egg retrieval, regardless of group assignment.
When partners are present and consent to the study, they will be treated as a dyad with the patient undergoing oocyte retrieval. Some patients go through treatment alone (i.e. single adults desiring pregnancy) and therefore may not have a partner available to participate. Partners level of involvement in a cycle may very, as may their desire to participate in a psychosocial intervention. As patients and their partners make joint decisions throughout their IVF cycle and the cycle itself has a single outcome, we enrolled partners as dyads with patients when partners were present, but did not require a partner to enroll a patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CALM IVFStandard of care in vitro fertilization patients randomized to the psychoeducational group intervention. |
| Control | Other | Other: Standard of CareStandard of care in vitro fertilization patients at our institution. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients starting their first in vitro fertilization cycle at the University of Iowa Hospitals and Clinics
Key exclusion criteria (5 listed)
- Patients who have already undergone in vitro fertilization treatment at any institution
- Non-English speakers
- Fertility preservation patients
- Patients using donor oocytes, embryos, or sperm
- Patients taking psychotropic medications for depression or anxiety that have had a dosing adjustment within 3 months of study enrollment
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 |
|---|---|---|
| CALM IVFThe intervention will be three 1-1.5 hour interactive sessions that are scheduled throughout the participant's first in vitro fertilization cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques. | Behavioural | Intervention |
| Standard of CarePatients will receive the standard of care IVF treatment at the University of Iowa. | Other | Control |
Primary outcome
Change in female fertility patient quality of life score during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
FertiQoL International (Fertility Quality of Life Questionnaire 2008), scored scale from 0-100, with higher values indicating a higher quality of life and low scores indicating a lower quality of life.
10 secondary outcomes
Change in female GAD-7 score during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Change in female PHQ-9 score during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Change in female Connor-Davidson Resilience Scale during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Change in female knowledge assessment during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Likelihood of continued IVF treatment in the instance of a negative pregnancy test
Time frame: Three months after embryo transfer
Change in male fertility patient quality of life score during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Change in male GAD-7 score during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Change in male PHQ-9 score during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Change in male Connor-Davidson Resilience Scale during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
Change in male knowledge assessment during IVF treatment cycle
Time frame: From enrollment to 2-4 days after oocyte retrieval
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 2 Oct 2026.
- Derived from this study: PubMed 36959953Whynott RM, Summers KM, Mejia RB, Segre LS, Ryan G, Pawlak SA. Creating affiliations, learning, and mindfulness for in vitro fertilization patients (CALM IVF): a clinical trial. F S Rep. 2023 Jan 7;4(1):61-71. doi: 10.1016/j.xfre.2023.01.002. eCollection 2023 Mar.
- 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.
Rachel M Whynott, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALM IVF in people with Quality of Life and IVF, run by University of Iowa at 1 site in United States.
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 1 inclusion and 5 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 2 Oct 2026. 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 United States. 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?
Change in female fertility patient quality of life score during IVF treatment cycle (time frame: From enrollment to 2-4 days after oocyte retrieval). 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 NCT04048772, which also lists 1 linked publication.
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 2 Oct 2026.