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InfertilityNCT07459894

Levine's Conservation Model-Based Nursing Care

A study testing Levin's conservative model- based nursing care in people with Infertility, run by Fayoum University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Infertility is a significant health problem, and the prevalence of infertility is increasing in developing countries. The WHO estimates that 8%-10% of married women experience difficulties in becoming pregnant. Read more about this study

Who is it for?
Ages 20 to 44 years, women only
Conditions the study is for
Infertility
What is being tested?
Levin's conservative model- based nursing care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
15 Apr 2025to 25 Dec 2025
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 20 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women aged 20-44 years
  • Diagnosis of secondary infertility
  • Undergoing fertility treatment regimen
  • Willing to participate in the study.

Who cannot join

  • Diagnosis of systemic and chronic diseases
  • Diagnosis of cognitive impairments according to patients' file or record

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University

    Shibīn al Kawm, Menoufia Governorate, 32511

Other trials in Egypt

About this study

Official title: Levine's Conservation Model-Based Nursing Care: A Framework for Enhancing Psychological Adaptation, Perception, and Social Support in Infertile Women: A Randomized Controlled Trial

Infertility is a significant health problem, and the prevalence of infertility is increasing in developing countries. The WHO estimates that 8%-10% of married women experience difficulties in becoming pregnant. While many women who experience infertility can become pregnant through assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF). IVF treatment can result in various psychological-emotional consequences, including stress, anxiety, depression, and hopelessness. This study aimed to evaluate the effect of nursing care based-levin's conservative model on psychological adaptation, perception and perceived social support in infertile women. Study design was a randomized controlled trial (RCT) research design. The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University, that allocated in Menoufia Governorate, Egypt. The study sample was a purposive sample of 80 infertile women attended the previously mentioned settings and was divided equally into study and control group (40 women). Four tools were used for data collection: A structured interviewing questionnaire, psychological adaptation tools, infertility perception scale for women (IPS-W and the multidimensional perceived social support scale.

Read the detailed description

Introduction Infertility is one of the most common chronic diseases among people of childbearing age. Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. affecting roughly 8% to 12% of reproductive-aged couples worldwide, the worldwide prevalence of involuntary childlessness varies between 52.6 and 200 million couples, the majority being residents of low- and middle-income countries (LMICs). Infertility can be primary or secondary. Primary infertility is when a pregnancy has never been achieved by a person, and secondary infertility is when at least one prior pregnancy has been achieved. Infertility may occur due to male, female or unexplained factors. Some causes of infertility are preventable. Treatment of infertility often involves in-vitro fertilization (IVF) and other types of medically assisted reproduction.

Despite of recent data on infertility globally are lacking, it has been estimated that 48 million couples and 186 million individuals worldwide live with infertility. Additionally, 12% of Egyptian couples have infertility, according to research by the Egyptian Fertility Care Society that was funded by the World Health Organization (WHO). 7.7% of them experience secondary infertility, while 4.3% experience main infertility.

Through the application of Levine's Conservation Model, the study highlights the vital role of nurses in promoting holistic adaptation and resilience during infertility treatment. Moreover, the outcomes can inform policy development and clinical guidelines that prioritize comprehensive, patient-centered care, thereby ensuring that infertile women receive not only medical treatment but also the emotional and social support necessary to thrive.

Aim The present study aims to evaluate the effect of nursing care based on Levine's Conservation Model on psychological adaptation, perception and perceived social support in infertile women. Research Hypotheses

  1. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher perception scores post-intervention than women who receive routine care.
  2. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher psychological adaptation scores post-intervention than women who receive routine care.
  3. Infertile women who receive nursing care based on Levine's Conservation Model are expected to have higher social support scores post-intervention than women who receive routine care.

Method Research Design A randomized controlled trial (RCT) research design was employed to examine the effect of nursing care based on Levine's Conservation Model on perception, psychological adaptation, and perceived social support among infertile women undergoing infertility treatment. This design was chosen because it is the most rigorous method of determining whether a cause-effect relationship exists between an intervention and outcome.

Study Setting The study was conducted at the obstetrics and gynecology outpatient clinic and In vitro fertilization (IVF) at Menoufia University, that allocated in Menoufia Governorate, Egypt. It is a specialized outpatient clinic that provides diagnostic and therapeutic services for couples experiencing infertility. The setting was selected because it attracts a large number of women with primary and secondary infertility, thus providing an adequate sampling frame for the research studies.

A purposive sample of 80 diagnosed infertile women was selected from outpatient clinic according to the inclusion criteria. Each woman was allocated to either the intervention or control group through a coin toss conducted by the researcher. Due to some women are dropped out, recruitment continued until both groups reached the required sample size. If the coin toss directed a new woman to a group that had already reached its target number, that woman was not enrolled, and the researcher continued tossing the coin until a woman was assigned to the group that still needed members. This procedure was repeated until the intended number for both groups was fulfilled. They were divided into two equal groups: Group I (experimental group), composed of 40 women, educational conservation nursing intervention in addition to their medication regimen, while group II (control group), composed of 40 women received their medication regimen only. To avoid contamination between groups, each woman was selected only after the previously assigned woman had completed and exited the outpatient clinic.

Study limitations

  • Infertility is emotionally sensitive; participants may withdraw or avoid discussing their feelings, affecting data completeness. This overcomes by ensure privacy during data collection. Train researchers in empathetic communication. Provide the option to skip questions that feel uncomfortable. Offer counseling referrals if needed.
  • Women differ in duration of infertility, previous treatments, and cultural beliefs-these can influence psychological status. This overcomes by using statistical controls (e.g., covariates) to manage confounding variables. Clearly define inclusion/exclusion criteria.
  • Participants in the control group may unintentionally receive information or support similar to the intervention group. This overcomes by scheduling sessions separately, using different staff for intervention vs. control groups. Keep materials inaccessible to the control group during the study.
  • Participants may skip some sessions due to clinic schedules, stress, or treatment commitments. Offering flexible session times, reminders (phone, SMS), shorten sessions or offer hybrid formats (in-person + online) are solutions to overcoming this issue.
Conditions
Infertility
Being tested
Levin's conservative model- based nursing care
Keywords
Levin's conservative model, Psychological adaptation, Social support, Perception of infertility, Nursing care
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levin's conservative model- based nursing careBehavioural

    The intervention was designed according to Levine's four conservation principles (energy, structural integrity, personal integrity, and social integrity). It consisted of weekly face-to-face educational sessions lasting 45-60 minutes over 7 consecutive weeks, delivered to the study group only (Group I). Sessions were interactive, employing lectures, discussion, role-playing, and multimedia aids. Participants received educational booklets to reinforce learning capabilities at their homes.

Study groups in NCT07459894
Study groupRoleWhat they receive
The first arm was called the experimental groupExperimentalThe first Arm: the study variables were measured before the implementation of Levin's conservative model-based nursing care in the experimental group then they were again assessed after the intervention in the experimental group.
Receives: Behavioral: Levin's conservative model- based nursing care
The second arm was called the control group.No interventionThe second arm: The control group who didn't receive any intervention were assessed before and after the implementation of Levin's conservative model-based nursing care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological adaptation

    Psychological adaptation tool included the following two scales:

    1. Infertility psychological distress scale (Jiang et al., 2025): The IPDS provides a novel and reliable tool for assessing the infertility psychological distress of women undergoing ART. It consists of 25 items across 2 dimensions: Distress of disrupting the former self and Distress linked to the struggling present self.

    II. Fertility Adjustment Scale (FAS) (Glover et al., 1999): it can be used to assess the psychological reactions to fertility problems and outcomes of treatment. Participants were asked to rate their agreement or disagreement with each statement using a scale that ranged from 1 = strongly disagree to 6 = strongly agree. The minimum possible score was 12 and the maximum score was 72.

    Measured: This outcome was measured a baseline data, then it was again measured after two months of the intervention.

Secondary outcomes (2)
  1. The infertility perception

    This outcome was measures using the infertility perception scale for women (IPS-W): (Ban Kim2024) This scale reflects the perception of infertility among women who are experiencing infertility and their spouse, family, and friends .It consists of a 4-point Likert scale with 21 items under four factors [ Factor-1 was named "perceived feelings," consisting of six items, Fac¬tor-2 was named "personal stigma," consisting of eight items, Factor-3 was named "social stigma," consisting of three items, and Factor-4 was named "acceptance," consisting of four items . The scale has a score range of 21-84 points, with higher scores indicating more negative perception.

    Measured: This outcome was measured a baseline data, then it was again measured after two months of the intervention.

  2. Social Support

    This outcome was measured using The Multidimensional Scale of Perceived Social Support (MSPSS) is a widely used self-report instrument designed to assess an individual's perceived adequacy of social support from three distinct sources: family, friends, and a significant other. The scale consists of 12 items, divided into three subscales: family support, friends support, and significant other support. Each subscale contains 4 items, allowing both subscale scores and a total social support score to be calculated. The Items are rated on a 7-point Likert scale, ranging from (1 = Very strongly disagree) to (7 = Very strongly agree). Higher scores indicate greater perceived social support.

    Measured: This outcome was measured a baseline data, then it was again measured after two months of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start15 Apr 2025
  3. Primary completion3 Jul 2025
  4. Study completion25 Dec 2025

Resources

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
Model description
A randomized controlled trial (RCT) research design was employed to examine the effect of nursing care based on Levine's Conservation Model on perception, psychological adaptation, and perceived social support among infertile women undergoing infertility treatment.
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459894
Sponsor's protocol ID
Study approved with No. 996
Status last verified
Feb 2026
First submitted
26 Feb 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared due to ethical restrictions and absence of participant consent for data sharing.

Publications

  • Sharma A, Shrivastava D. Psychological Problems Related to Infertility. Cureus. 2022 Oct 15;14(10):e30320. doi: 10.7759/cureus.30320. eCollection 2022 Oct.

    PubMed 36407201
  • Ramadan S& Said A. (2018) Effect of an Educational Intervention for Infertile Women Regarding Natural Fertility Methods and Sexual Skills for Improving Sexual Function. American Journal of Nursing Research, Vol. 6, No. 1, 1-11

  • Hussein M. 2024. Environmental Risk Factors for Infertility Focusing on Egypt: A Narrative Review. Journal of High Institute of Public Health;54(1):40-47

  • Moura-Ramos, M., & Gameiro, S. (2021). Role of psychosocial interventions in infertility care: A systematic review. Current Opinion in Obstetrics & Gynecology, 33(3), 158-164.

  • Sullivan EA, Zegers-Hochschild F, Mansour R, Ishihara O, de Mouzon J, Nygren KG, Adamson GD. International Committee for Monitoring Assisted Reproductive Technologies (ICMART) world report: assisted reproductive technology 2004. Hum Reprod. 2013 May;28(5):1375-90. doi: 10.1093/humrep/det036. Epub 2013 Feb 26.

    PubMed 23442757
  • Özcan, H., & Kirca, N. (2023). Nursing care based on Levine's model improves psychological well-being in infertile women undergoing ART. Journal of Advanced Nursing, 79(5), 2111-2121.

  • Saini NK, Kalia R. (2019). Levine's Conservation Model of Health. Asian J. Nursing Education and Research.; 9(3):466-468. DOI: 10.5958/2349-2996.2019.00097.1

  • 5- Levine, M. E. (2020). The Conservation Model: A framework for nursing practice (Updated edition). Nursing Science Quarterly, 33(4), 356-362.

  • Gurunath S, Pandian Z, Anderson RA, Bhattacharya S. Defining infertility--a systematic review of prevalence studies. Hum Reprod Update. 2011 Sep-Oct;17(5):575-88. doi: 10.1093/humupd/dmr015. Epub 2011 Apr 14.

    PubMed 21493634
  • Boivin J, Gameiro S. Evolution of psychology and counseling in infertility. Fertil Steril. 2015 Aug;104(2):251-9. doi: 10.1016/j.fertnstert.2015.05.035. Epub 2015 Jun 16.

    PubMed 26092131

Questions about this trial

What is this clinical trial studying?

A study testing Levin's conservative model- based nursing care in people with Infertility, run by Fayoum University at 1 site in Egypt.

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 4 inclusion and 2 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 10 Mar 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 Egypt. 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?

Psychological adaptation (time frame: This outcome was measured a baseline data, then it was again measured after two months of the intervention.). 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 NCT07459894, which also lists 10 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 10 Mar 2026.

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