# Psychological evaluation of candidates for the uterus transplantation French trial

Léa Karpel, Marie Carbonnel, Catherine Racowsky, Paul Pirtea, Jean Marc Ayoubi, Margaux Nicaise, Mathilde Le Marchand

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Léa Karpel, Marie Carbonnel, Catherine Racowsky, Paul Pirtea, Jean Marc Ayoubi, et al.. Psychological evaluation of candidates for the uterus transplantation French trial. Acta Obstetricia et Gynecologica Scandinavica, 2025, 104 (3), pp.522-527. 10.1111/aogs.15004. hal-05029278

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# Psychological evaluation of candidates for the uterus transplantation French trial

Léa Karpel<fnref n="1" />

Margaux Nicaise<fnref n="2" /> ID

Marie Carbonnel<fnref n="1" />,<fnref n="3" /> ID

Mathilde Le Marchand<fnref n="4" />

Catherine Racowsky<fnref n="1" />

Paul Pirtea<fnref n="1" />

Jean-Marc Ayoubi<fnref n="1" />,<fnref n="3" />

## Correspondence

Léa Karpel, Department of Obstetrics, Gynecology and Reproductive Medicine, Hospital Foch, 40 Rue Worth, Suresnes, Île-de-France 92150, France.
Email: l.karpel@hopital-foch.com

## Funding information

Foch foundation; University of Versailles Saint-Quentin-en-Yvelines transplantation chair

## Abstract

**Introduction:** Since 2017, women with absolute uterine infertility due to Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome have been eligible to participate in a uterine transplantation clinical trial conducted by Foch Hospital in France. The aim of this study is to assess the psychological state of potential candidates, including recipients, their partners, and their living-related donors.

**Material and Methods:** Sixteen potential uterus transplant candidates, including recipients, partners, and living-related donors, participated in the study. The psychological evaluation of these candidates was conducted using three validated questionnaires: the Dyadic Adjustment Scale (DAS-16), the Hospital Anxiety and Depression Scale (HADS), and the Fertility Quality of Life (FertiQoL) questionnaire.

**Results:** No depression symptoms were observed in any participant according to the HADS. Most recipients did not exhibit signs of anxiety; however, three partners and three donors reported moderate to high anxiety levels. A positive correlation was found between the recipient's psychological distress related to infertility (FertiQoL) and the anxiety scores of their donors. The emotional aspect of infertility was identified as the most distressing factor for the recipients.

**Conclusions:** While the overall psychological state of the participants was generally good, anxiety was notably present among donors and partners. Therefore, providing psychological support throughout the uterine transplantation process is essential for not only the recipients but also their partners and donors.

## KEYWORDS

anxiety, assessment scales, infertility, psychology, quality of life, uterine transplantation

# 1 | INTRODUCTION

Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome is characterized by a congenital absence of the uterus with an estimated prevalence

of one in 4500 women.<fnref n="1" /> The discovery of this syndrome, often during adolescence when menstruation is absent, can lead to various psychological consequences for affected individuals, including eating disorders, depression, or disruptions in their schooling.<fnref n="2" />,<fnref n="3" /> Diagnosed

**Abbreviations:** DAS-16, Dyadic Adjustment Scale; FertiQoL, Psychological distress regarding infertility questionnaire; HADS, The Hospital Anxiety and Depression Scale; IVF, in vitro fertilization; MRKH, Mayer-Rokitansky-Küster-Hauser; UTx, uterus transplantation.

This is an open access article under the terms of the [Creative Commons Attribution-NonCommercial-NoDerivs License](https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

© 2024 The Author(s). *Acta Obstetricia et Gynecologica Scandinavica* published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

<footnote n="1">¹Department of Obstetrics, Gynecology and Reproductive Medicine, Foch Hospital, Suresnes, France</footnote>

<footnote n="2">²Department of Psychopathology, University of Paris, Paris, France</footnote>

<footnote n="3">³University of Versailles-Saint-Quentin-en-Yvelines, Montigny-Le-Bretonneux, France</footnote>

<footnote n="4">⁴Department of Clinical Research, Foch Hospital, Suresnes, France</footnote>
women often experience low sexual self-esteem and significant psychological distress.³ MRKH significantly impairs their quality of life.⁴ Understanding that they will never be able to become pregnant can be particularly painful.⁵,⁶ Surrogate motherhood, as an alternative, is prohibited in many countries, including France, leaving patients with limited options.⁷ Today, uterine transplantation (UTx) offers these women the opportunity to experience biological, social, and legal parenthood.⁸

UTx is currently being performed through various clinical trials worldwide.⁹,¹⁰ To date, more than 91 cases of UTx have been reported from both living and deceased donors, resulting in 49 healthy children born (40 from living donors and nine from deceased donors).⁹ The UTx procedure involves a temporary transplant: the uterine graft is removed after one or two successful pregnancies or after a maximum of 5 years. However, the UTx protocol is complex and does not guarantee a 100% success rate. It involves in vitro fertilization (IVF), long and complicated surgery, immunosuppressive treatment, monitoring of high-risk pregnancies, and potential complications at any step of the process (graft rejection, pregnancy loss, etc.). The overall success rate of the surgery (functional graft 3 months after transplantation) is around 70%, with 50% of all recipients giving birth to a healthy child.¹¹,¹² Despite the challenges associated with the transplant process, couples with an absolute uterine factor infertility tend to prefer UTx over adoption or surrogacy.¹³⁻¹⁵ Indeed, for the majority, the benefits of UTx outweigh the risks.¹⁵⁻¹⁷

Nevertheless, as with most organ transplants, UTx impacts not only the physical health of the patient and the living donor, but also their mental health. An essential aspect of the selection process is evaluating the psychological state of the candidates.¹¹,¹² Beyond psychological evaluation, psychological support is a crucial component in UTx programs.⁴ Understanding the psychological and emotional aspects of participating in an UTx procedure requires further elucidation. The present study aims to contribute to this understanding by evaluating anxiety, depression and quality of life for recipients, their partner and their living donor during the preselection phase for inclusion in our clinical trial. The primary objective of the study was to assess the mental health of all potential UTx trial participants after being pre-selected by an independent committee.

## 2 | MATERIAL AND METHODS

### 2.1 | Patient inclusion criteria and preselection process

This research is a quantitative, descriptive and prospective study. Patients were preselected for the UTx Foch Hospital clinical trial (NCT 03689842) from 2017 to 2023 and this study was approved by the local ethics committee (IRB 00012437). All our patients were exclusively part of the UTx trial at Foch Hospital in France. This Department of Obstetrics, Gynecology and Reproductive Medicine has initiated a trial involving 10 UTx procedures with living donors. The trial is accepted only for heterosexual couples where the recipient suffers from MRKH syndrome. The couple

**Key message**

Psychological evaluation of potential candidates for the uterus transplantation French Trial shows that providing psychological support is essential throughout all the process until explanation.

must present a related living donor (family member or friend), aged over 40 years old.

Our preselection process involves reviewing the medical and socio-demographic history and conducting clinical examinations. The inclusion criteria of recipients are: women with MRKH syndrome, without prior surgery of vagina, no toxic use (alcohol, drugs, and cigarette), no psychologic issues, with a normal BMI, aged between 18 and 38 years old, in a stable heterosexual relationship since at least 3 years with a man with normal semen parameters and with an identified living relative donor. No gamete donation is allowed and the couple must create at least 10 embryos by IVF before the surgery. The inclusion criteria for donors are: aged between 40 and 65 years old, having given birth only vaginally, no toxic use (alcohol, drugs, and cigarette), no history of serious illness, no psychologic issues, a normal BMI and immunological compatibility with the recipient. Members of each triad (recipient, partner, and donor) meet with a committee, no member of which is staff in the trial. This committee is composed of a psychiatrist, a psychologist, a transplant surgeon, an anesthetist and a gynecologist to explain the process and check for any medical or psychological contraindications.¹⁸ A psychological evaluation performed by the psychologist and the psychiatrist of the committee for the triad is also necessary for inclusion. After 3 months of consideration, the triad reconvenes with the committee to provide consent for inclusion in the selection process. A psychologist dedicated to the trial then interviews the triad after they have completed the psychological tests reported in this study. The psychologist will follow up with donor for 1 year after explantation, and for years with the recipient and her partner. The psychological tests described here are repeated during the UTx process. The French Biomedicine Agency does not permit the psychologist to meet with excluded triads.

### 2.2 | Psychological testing

Each member of the triad, separately, fulfills psychological tests after the preselection of the committee, before the psychological interview, days before getting know if they can be included definitely in the trial so before IVF and surgery. Three tests are submitted: The Hospital Anxiety and Depression Scale (HADS) for both three, the Fertility Quality of Life (FertiQoL) and the Dyadic Adjustment Scale (DAS-16) for the couple only.

The HADS test¹⁹ measures anxiety, depression, and overall psychological distress.²⁰ Seven items explore depressive
symptomatology and seven others assess anxiety symptomatology. The score for each dimension ranges from 0 to 21. A score between 8 and 10 indicates moderate anxiety and/or depressive symptomatology and a score above 10 indicates a markedly anxious and/or depressive state.

The FertiQoL test²¹ is a quality-of-life scale which measures the quality of life of individuals experiencing fertility difficulties. It consists of 34 items divided into two subtests: 24 items focus on the experience of infertility and 10 on infertility treatments. For our study, only the first subscale (24 items) was proposed, because candidates had not yet undergone in vitro fertilization during their first hospital visit. This subscale contains four dimensions that measure the impact of infertility on: physical and psychological manifestations (fatigue, pain, cognitive, or behavioral problems and daily life challenges); emotional state (jealousy, resentment, sadness, or depression); marital life (sexuality, communication, etc.); and social life (feelings of exclusion, stigmatization, expectations of relational support). The normative mean value of the scale is 55.3 (of 100); consequently, individuals with a score below this threshold are deemed to have a painful experience of infertility.

The DAS-16²² is a scale which measures marital adjustment and consists of 16 items divided into two sub-sections: the degree of agreement in the couple and the quality of interactions between partners. A score above 54 is considered to represent satisfactory adjustment.²³

Quantitative results are presented as the median (min-max). To compare the results, Mann-Whitney and Chi squared U tests were performed and a correlation analysis was conducted with a significance threshold set at 95%. Pearson correlations were applied to the HADS scores since the data did not follow a normal distribution as determined by the Shapiro-Wilk test. A *p*-value of less than 0.05 was considered statistically significant.

## 3 | RESULTS

To date, the Department has received over 300 candidates for UTx.¹⁸ However, due to various exclusion criteria (such as immunological, gynecological, and reproductive factors) and after an initial assessment, only 20 candidates, with their partner and donor, were selected to meet with an independent committee for further evaluation. From this pool, 18 triads confirmed their desire to be included in the UTx trial. Two of these were excluded

because their questionnaires, completed before 2018, did not meet the ethical requirements of research in France. Finally, 16 triads were included in the present study. The mean age of the recipients was 28.9 years old (22–35), of partners was 31.4 years old (21–46) and of donors 53.5 years old (40–65). The potential donors were mainly the recipient's mothers (n = 12), with a smaller proportion including a sister-in-law (n = 1), a sister (n = 1), and two mothers-in-law. Recipients had been aware of their MRKH diagnosis since a median age of 16.5 years (14–31).

The median HADS anxiety score of recipients was 5 (2–7) and their median depression score was 1 (0–3) indicating no anxious or depressive symptomatology. Among the partners, the median HADS anxiety score was 5 (2–13), and their median depression score was 1 (0–6). No partner had a score indicating depressive symptomatology but three partners had elevated anxiety scores. Of these, two partners had scores above 10 (11 and 13), indicating high anxiety symptomatology and one partner had a score of 8, indicating moderate anxiety symptomatology. Among the donors, the median anxiety score was 5 (1–11) and their mean depression score was 1 (0–5). No donor had a score indicating depressive symptomatology, but three donors had high anxiety scores: two scored 8.0, indicating moderate anxiety symptoms, and one scored over 10 (11), indicating severe anxiety symptoms. There was no significant difference in anxiety and depression level, between recipients or partners, nor between recipients and donors. Those results are summarized in Table 1.

We analyzed the FertiQoL questionnaires of 15 partners and 16 recipients. Partners and recipients had globally comparable results with median scores of 91.7 for partners (73–98) while recipients had a median score of 90.6 (85.5–99). One woman reached the threshold of 56 in the emotional dimension, indicating a prevalence of negative reactions to infertility such as jealousy, resentment, sadness, or depression. No statistically significant differences were observed between recipients and partners for any of the four broad metrics assessed (Table 2).

However, there was a significant correlation between the donors' total HADS score and the recipients' infertility experience (FertiQoL) (*p* = 0.04). No correlation existed between recipients' total HADS scores and their infertility experience (FertiQoL) (*p* = 0.96), nor between partners' total HADS scores and recipients' infertility experience (FertiQoL) (*p* = 0.97).

The dyadic adjustment (DAS-16) score involved recipients and their partners. Data from three partners and two recipients could not be analyzed due to incomplete questionnaire responses. In total,

<table><caption>TABLE 1 HADS scores for anxiety and depression of the triads.</caption><thead><tr><th></th><th>Recipient (n=16)</th><th>Partner (n=16)</th><th>Donor (n=16)</th><th>Recipient vs. Donor p-value</th><th>Recipient vs. Partner p-value</th></tr></thead><tbody><tr><td>Anxiety score</td><td>5.0 (2.0-7.0)</td><td>5.0 (2.0-13.0)</td><td>5.0 (1.0-11.0)</td><td>0.98</td><td>0.37</td></tr><tr><td>Depression</td><td>1.0 (0.0-3.0)</td><td>1.0 (0.0-6.0)</td><td>1.0 (0.0-5.0)</td><td>0.88</td><td>0.53</td></tr><tr><td>Total</td><td>5.5 (2.0-10.0)</td><td>6.5 (2.0-16.0)</td><td>6.5 (2.0-11.0)</td><td>0.31</td><td>0.26</td></tr></tbody></table>

Note: Values are given as median (range).
<table><caption>TABLE 2 FertiQoL scores.</caption><thead><tr><th></th><th>Recipients (n=16)</th><th>Partners (n=15)</th><th>p-value</th></tr></thead><tbody><tr><td>Somatic and psychological manifestations</td><td>95.8 (79.0-100.0)</td><td>95.8 (83.3-100.0)</td><td>0.76</td></tr><tr><td>Emotional reaction</td><td>87.5 (54.2-100.0)</td><td>95.8 (70.8-100.0)</td><td>0.10</td></tr><tr><td>Marital impact</td><td>91.7 (70.8-100.0)</td><td>95.8 (79.2-100.0)</td><td>0.25</td></tr><tr><td>Social impact</td><td>87.5 (66.7-100.0)</td><td>91.7 (66.7-100.0)</td><td>0.86</td></tr><tr><td>Total</td><td>90.6 (85.5-99.0)</td><td>91.7 (73.0-98.0)</td><td>0.25</td></tr></tbody></table>

Note: Values are given as median (range).

<table><caption>TABLE 3 Dyadic Adjustment Scale results.</caption><thead><tr><th></th><th>Recipients (n=14)</th><th>Partners (n=13)</th><th>p-value</th></tr></thead><tbody><tr><td>Adhesion degree</td><td>55.0 (40.0-59.0)</td><td>54.0 (47.0-58.0)</td><td>0.21</td></tr><tr><td>Quality of interactions</td><td>33.0 (20.0-36.0)</td><td>28.0 (23.0-35.0)</td><td>0.32</td></tr><tr><td>Total</td><td>88.5 (60.0-95.0)</td><td>83.0 (70.0-92.0)</td><td>0.24</td></tr></tbody></table>

Note: Values are given as median (range).

27 questionnaires were analyzed: 14 from recipients and 13 from their partners. The responses indicated that all participants reported good marital satisfaction, with no statistically significant differences in scores between recipients and partners (Table 3).

## 4 | DISCUSSION

The psychological state of the 16 potential recipients, their partner and donor included was generally good during the preselection phase of our UTx trial. However, we revealed moderate to elevated anxiety levels among three potential donors and three partners. A positive correlation was observed between the recipient's psychological distress regarding infertility and the anxiety scores of their donors.

The results concerning anxiety and depression in our candidates were almost similar to those of the first nine candidates and their partners at the time of inclusion in the first UTx trial in Sweden.⁴ Only the anxiety rates of French partners' candidates were slightly higher. The results of the HADS questionnaires completed by potential recipients showed low scores of anxiety and depression. In contrast, assisted reproductive techniques (ART) trials are known to provoke anxious and/or depressive symptomatology in patients during IVF: 14.7% of women and 4.5% of men develop anxious symptoms, while 17.9% of women and 6.9% of men develop depressive symptoms.²⁴ One hypothesis is that potential recipients, tend to present themselves free from anxiety and depression, fearing rejection from the transplantation program. Additionally, the possibility of benefiting from UTx generates so much hope that, at the time of completing the questionnaires, (before definitive acceptation), the potential recipients experience a real joyful excitement.⁹ The second hypothesis could be a recipient's negation of surgical risks for her and the donor: recipient's surgery lasts an

average of 5h and more than 30% have experienced grade 3 complications according to the Dindo-Clavien classification, which involves the need for reoperation.¹¹,²⁵ The donor's surgery lasts on average over 10h¹¹ even with robotic tools. More than 17% of donors have experienced grade 3 complications according to the Dindo-Clavien classification.¹¹ Even if the success rate of the surgery is approximately 70%, the chance to deliver a healthy child is only 50% among those who have been transplanted.¹¹,²⁶ Finally, if their UTx fails, they will return to the infertile status.²⁷ Despite our hypothesis of risks negation, one article described that potential recipients experience fear for donor health, embarrassment, anxiety and guilt for the involvement of a healthy donor.⁹

The low level of recipient's anxiety could be explained by the fact that couples willing to be included in our UTx trial are also well-informed and sometimes engaged in others parenthood options, such as gestational surrogacy or adoption, either prior to, or simultaneously, with their UTx desire.²⁷,²⁸ Contrary to France, in some countries, access to UTx may be denied if the couple is currently pursuing gestational surrogacy.²⁹

The FertiQoL results showed that the overall experience of infertility impacted the most the emotional dimension of recipients. Women with MRKH often suffer emotionally, experiencing feelings of jealousy and resentment against fertile women (including their mother, sisters, and friends), as well as sadness and depression regarding their infertility.²,³,⁶,²⁷ Because MRKH syndrome does not involve any visible disabilities or physical pain, its social impact is less significant. The DAS-16 did not reveal any conjugal issues. However, the recipients believe that the marital relationship stability could be called into question in the long term if they are unable to have a child with their fertile partner.³⁰

Our data showed that partners included in our UTx trial were more likely to present with higher scores of anxiety than men undergoing ART (18.8% vs. 4.5%).²⁴ One hypothesis for this observation could be their potential worries about the surgical risks of both their partner and her donor (mainly their mother-in-law).²⁷ However, the fear of losing their partner was not overshadowed by the hope that the UTx represents for their partner. As the men did not experience the infertility themselves, they did not share the same level of expectations as their partners. If the UTx failed, they would be the main support for the recipient.

Concerning the donors, the only significant correlation showed that the more the recipient struggles with her infertility, the more anxiety symptoms may appear in them. Their anxiety can
be explained by the complex interrelations between mothers and children. Indeed, this unique uterine transplant, involving often a mother as a donor and a daughter as a recipient, addresses deep issues about femininity, filiation, and motherhood, enabling childbirth for the recipient and a form of repair for her mother.

Moreover, we do not know the exact etiology of the MRKH syndrome, a genetic origin is not ruled out.³¹ Even if the altruistic aspect of the uterus graft gift is expected, the potential donor, most often the mother, express guilty towards her daughter's malformation, which is common in families with genetic diseases.²,³² Thanks to UTx the mother could redeem herself for having given birth to a daughter who cannot become a mother.²⁷ Therefore, it is important to ensure during the UTx preselection process that there is no conscious or unconscious pressure on the donor. The use of deceased donors in a UTx trial, as realized in some other countries¹¹ could reduce the pressure on potential living-related donors.

The main limitation of our study is the small number of patients included. Furthermore, participants' answers were potentially biased by the fear of UTx trial rejection. In future analyses, it will be interesting to re-evaluate the candidates after rejection from our UTx trial. Despite this, we were able to highlight psychological elements that demonstrate the complex interactions between the donor-recipient triad and the transplant partner. Together, our findings- about recipient's, donor's and partner's anxiety, highlight the importance of psychological evaluation and support for all three members during the whole process of UTx.

## 5 | CONCLUSION

This study, which focused on the mental health of candidates for UTx, demonstrated psychological well-being among the participants during their initial preselection before knowing if they were included in the trial. Instances of anxious and depressive symptoms were rare for UTx candidates. Notably, the emotional state of the potential donor appeared to be closely linked to the recipient's painful experience of infertility, likely due to their close relationship and the emotional burden it carries. The study highlighted that future donor, whether a mother or a close relative, exhibited heightened sensitivity to the recipient's infertility experience, leading to potential anxious symptoms in these donors.

Interestingly, both the potential donor and the recipient's partner exhibited higher levels of anxiety compared to the potential recipient. Consequently, the study supports the necessity of ongoing support for the triad throughout the entire process. Such follow-up would be beneficial for the triad's inclusion until the birth of the child and the removal of the uterine graft. Furthermore, the potential recipient faces the risk of depression in case of refusal, failure, loss of graft, or uterine removal, which could return her to the emotionally challenging state of being sterile. The partner and potential donor will have to manage their anxiety during the surgery and pregnancy, considering the medical risks for the donor and the future mother. The donor's relative, who is very sensitive to the painful experience

of her relative's infertility, may risk experiencing a renewed sense of guilt in case of failure, loss of the graft or fetal loss.

The UTx journey, which is above all a story of compassion filled with shared hopes but also potential failures and disillusionments, requires further study. More psychological data, including qualitative studies and long-term follow-up, is essential to refine our understanding of the mental health of recipients, their partners, and donors throughout the entire process of this unique transplantation. The goal of UTx is not merely to enhance the quality of life of women with absolute infertility but to enable the birth of a healthy child.

## AUTHOR CONTRIBUTIONS

Study conception and design: Léa Karpel, Mathilde Le Marchand. Data collection: Margaux Nicaise, Mathilde Le Marchand. Analysis and interpretation of results: Margaux Nicaise, Léa Karpel, Marie Carbonnel. Draft manuscript preparation: Margaux Nicaise, Marie Carbonnel, Léa Karpel, Catherine Racowsky, Paul Pirtea, Jean-Marc Ayoubi. All authors reviewed the results and approved the final version of the manuscript.

## ACKNOWLEDGMENTS

We thank the University of Versailles Saint Quentin en Yvelines Transplantation Chair and the Foch foundation for their support. From the Foch Hospital (Suresnes, France): We thank the Department of clinic research, especially F. Couppey for administrative supervision.

## FUNDING INFORMATION

This work was supported by the University of Versailles Saint-Quentin-en-Yvelines transplantation chair and the Foch foundation.

## CONFLICT OF INTEREST STATEMENT

The authors declare no conflict of interest.

## ETHICS STATEMENT

Study was approved by the local ethics committee (IRB 00012437) on the February 11, 2022.

## ORCID

Margaux Nicaise

<figure><img src="image_3.png" /></figure>

https://orcid.org/0009-0003-5168-238X

Marie Carbonnel

<figure><img src="image_4.png" /></figure>

https://orcid.org/0000-0001-9935-1203

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**How to cite this article:** Karpel L, Nicaise M, Carbonnel M, et al. Psychological evaluation of candidates for the uterus transplantation French trial. *Acta Obstet Gynecol Scand.* 2025;104:522-527. doi:10.1111/aogs.15004