Perinatal DisorderNCT05895175
Evolution of Maternal and Paternal-fetus Attachment in Egg Donation
An observational study of Perinatal Disorder, run by Fundación IVI at 3 sites in 3 countries.
Trial summary
Recently, many families have been formed through gamete donation, a reproductive treatment where the ensuing children do not share a genetic link with either parents. However, despite such an increase, little is known about the parent-child relationship. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Perinatal Disorder
- What is being tested?
- Questionnaires
- How many people
- 132 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Nov 2022to 30 Mar 2024
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The reference population includes all couples who have become pregnant in the selected IVI RMA clinics , through egg donation or standard IVF treatment, being the woman 40 years old or above, with no other specific indications (except individuals taking psychotropic drugs). Their native language must be English or Italian.
Who may be able to join
- getting pregnant through an egg donation program
- Own semen
- Native language must be English or Italian
- getting pregnant through a standard IVF treatment with own gametes
- Native language must be English or Italian
Who cannot join
- Patients failing to consent to be recontacted for research purpose.
- Patients who are taking psychotropic drugs
- Patients who got pregnant through sperm or embryo donation
- OWN GAMETE GROUP
- Patients failing to consent to be recontacted for research purpose.
- Patients who are taking psychotropic drugs
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Assessing the Evolution of Maternal and Paternal-fetus Attachment in Couples Conceiving Through Egg Donation
Recently, many families have been formed through gamete donation, a reproductive treatment where the ensuing children do not share a genetic link with either parents. However, despite such an increase, little is known about the parent-child relationship. Indeed, only two longitudinal studies have provided scientific background about family functioning in gamete donation. These studies showed that in egg donation families, the parent-child relationship was normal for parenting, parent psychological health, and child adjustment.
A more recent study evaluated mother-infant interaction in egg donation families comparing them with those created through IVF with their own gametes. Data collected showed that in egg donation families the mother-infant relationship quality appeared to be less optimal. Mothers were less interactive and stimulating, and infants showed lower involvement and less responsiveness with respect to their mothers Overall, the evidence suggests that women conceiving through egg donation likely require a variable period of adaptation to parenting. Here, the investigators aim to evaluate this interaction at an earlier stage, that is during the gestation. The specific bond that parents develop towards the fetus during pregnancy is called "parental-fetus attachment". Previous studies showed that the quality of the parental-fetus attachment is predictive of the quality of the postnatal parent-infant relationship and the child development The purpose is to evaluate whether the lack of genetic link with their offspring could undermine the parental attachment to the fetus, comparing couples conceiving through egg donation with those who get pregnant through a standard IVF treatment with their own gametes. No studies have been performed so far on this matter.
Read more
To assess the mother-father fetus attachment, the investigators will administer standardized and validated questionnaires to couples undergoing IVF with their own gametes, or egg donation cycles. For women, the investigators will use the Maternal Antenatal Attachment Scale . For men, the investigators will use the Paternal Antenatal Attachment Scale (PAAS-IT) . Furthermore, to also assess the emotional status of both partners, the investigators will use the Matthey Generic Mood Questionnaire .
Seeing that in the general population the maternal-fetal attachment level increases once women have completed the principal prenatal genetic screenings (like NIPT, CVS or amnio) and once they start perceiving the fetal movements, the investigators will administer the same questionnaire twice: between the 19-23 weeks and between the 28-32 weeks of gestation. This approach will enable monitoring of the evolution of the maternal and paternal fetal attachment at relevant gestational time-points.
As a result of the knowledge gathered from this study, the investigators will be able to develop a specific intervention strategy to promote this fundamental process for egg donation families.
- Conditions
- Perinatal Disorder
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| DONATED GAMETE GROUP | couples who got pregnant through egg donation (with their own semen) Receives: Other: Questionnaires | |
| OWN GAMETE GROUP | couples who got pregnant through standard IVF treatment, with their own gametes Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
validated questionnaire to assess the change of maternal fetus attachment (MAAS)
The MAAS total score is calculated by the sum of all item of the questionnaire, and the subscales score (quality and intensity of the attachment) are calculated through the sum of the rate of each item that is included in that scale. Scoring is 1-5, with 5 high attachment
Measured: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
validated questionnaire to assess the change of Paternal fetus attachment (PAAS)
The PAAS total score is calculated by the sum of all item of the questionnaire, and the subscales score (quality and intensity of the attachment) are calculated through the sum of the rate of each item that is included in that scale. Scoring is 1-5, with 5 high attachment
Measured: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
questionnaire to explore the change of the Emotional status (Anxiety or depression feelings) during pregnancy (MGMQ)
The MGMQ provideds a screen positive / negative classification of emotional distress
Measured: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Nov 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación IVI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895175
- Sponsor's protocol ID
- 2112-ROM-108-MF
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Evolution of Maternal and Paternal-fetus Attachment in Couples Conceiving Through Egg Donation
- ClinicalTrials.gov ID
- NCT05895175
- Acronym / sponsor ID
- 2112-ROM-108-MF
- Conditions
- Perinatal Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Fundación IVIUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 8 Jun 2023 (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.
Recently, many families have been formed through gamete donation, a reproductive treatment where the ensuing children do not share a genetic link with either parents. However, despite such an increase, little is known about the parent-child relationship. Indeed, only two longitudinal studies have provided scientific background about family functioning in gamete donation. These studies showed that in egg donation families, the parent-child relationship was normal for parenting, parent psychological health, and child adjustment.
A more recent study evaluated mother-infant interaction in egg donation families comparing them with those created through IVF with their own gametes. Data collected showed that in egg donation families the mother-infant relationship quality appeared to be less optimal. Mothers were less interactive and stimulating, and infants showed lower involvement and less responsiveness with respect to their mothers Overall, the evidence suggests that women conceiving through egg donation likely require a variable period of adaptation to parenting. Here, the investigators aim to evaluate this interaction at an earlier stage, that is during the gestation. The specific bond that parents develop towards the fetus during pregnancy is called "parental-fetus attachment". Previous studies showed that the quality of the parental-fetus attachment is predictive of the quality of the postnatal parent-infant relationship and the child development The purpose is to evaluate whether the lack of genetic link with their offspring could undermine the parental attachment to the fetus, comparing couples conceiving through egg donation with those who get pregnant through a standard IVF treatment with their own gametes. No studies have been performed so far on this matter.
To assess the mother-father fetus attachment, the investigators will administer standardized and validated questionnaires to couples undergoing IVF with their own gametes, or egg donation cycles. For women, the investigators will use the Maternal Antenatal Attachment Scale . For men, the investigators will use the Paternal Antenatal Attachment Scale (PAAS-IT) . Furthermore, to also assess the emotional status of both partners, the investigators will use the Matthey Generic Mood Questionnaire .
Seeing that in the general population the maternal-fetal attachment level increases once women have completed the principal prenatal genetic screenings (like NIPT, CVS or amnio) and once they start perceiving the fetal movements, the investigators will administer the same questionnaire twice: between the 19-23 weeks and between the 28-32 weeks of gestation. This approach will enable monitoring of the evolution of the maternal and paternal fetal attachment at relevant gestational time-points.
As a result of the knowledge gathered from this study, the investigators will be able to develop a specific intervention strategy to promote this fundamental process for egg donation families.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DONATED GAMETE GROUP | – | Other: Questionnairescouples who got pregnant through egg donation (with their own semen) |
| OWN GAMETE GROUP | – | Other: Questionnairescouples who got pregnant through standard IVF treatment, with their own gametes |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The reference population includes all couples who have become pregnant in the selected IVI RMA clinics , through egg donation or standard IVF treatment, being the woman 40 years old or above, with no other specific indications (except individuals taking psychotropic drugs). Their native language must be English or Italian.
Key inclusion criteria (5 listed)
- getting pregnant through an egg donation program
- Own semen
- Native language must be English or Italian
- getting pregnant through a standard IVF treatment with own gametes
- Native language must be English or Italian
Key exclusion criteria (6 listed)
- Patients failing to consent to be recontacted for research purpose.
- Patients who are taking psychotropic drugs
- Patients who got pregnant through sperm or embryo donation
- OWN GAMETE GROUP
- Patients failing to consent to be recontacted for research purpose.
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 |
|---|---|---|
| QuestionnairesQuestionnaires | Other | DONATED GAMETE GROUP, OWN GAMETE GROUP |
Primary outcome
validated questionnaire to assess the change of maternal fetus attachment (MAAS)
Time frame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
The MAAS total score is calculated by the sum of all item of the questionnaire, and the subscales score (quality and intensity of the attachment) are calculated through the sum of the rate of each item that is included in that scale. Scoring is 1-5, with 5 high attachment
validated questionnaire to assess the change of Paternal fetus attachment (PAAS)
Time frame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
The PAAS total score is calculated by the sum of all item of the questionnaire, and the subscales score (quality and intensity of the attachment) are calculated through the sum of the rate of each item that is included in that scale. Scoring is 1-5, with 5 high attachment
questionnaire to explore the change of the Emotional status (Anxiety or depression feelings) during pregnancy (MGMQ)
Time frame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
The MGMQ provideds a screen positive / negative classification of emotional distress
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 26 Feb 2025.
Related trials for Perinatal Disorder
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Disorder, run by Fundación IVI at 3 sites in 3 countries.
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 6 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Spain, United Kingdom. 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?
validated questionnaire to assess the change of maternal fetus attachment (MAAS) (time frame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2025.