Clinical trial NCT05895175: Evolution of Maternal and Paternal-fetus Attachment in Egg Donation
Official title: Assessing the Evolution of Maternal and Paternal-fetus Attachment in Couples Conceiving Through Egg Donation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perinatal Disorder
Lead sponsor: Fundación IVI
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: DONATED GAMETE GROUP

Inclusion criteria:

* getting pregnant through an egg donation program
* Own semen
* Native language must be English or Italian

Exclusion criteria:

* 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

Inclusion criteria:

* getting pregnant through a standard IVF treatment with own gametes
* Native language must be English or Italian

Exclusion criteria:

* Patients failing to consent to be recontacted for research purpose.
* Patients who are taking psychotropic drugs

Primary outcomes:
measure: validated questionnaire to assess the change of maternal fetus attachment (MAAS)
timeFrame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
measure: validated questionnaire to assess the change of Paternal fetus attachment (PAAS)
timeFrame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
measure: questionnaire to explore the change of the Emotional status (Anxiety or depression feelings) during pregnancy (MGMQ)
timeFrame: between 19-23 gestational weeks and follow up between 28-32 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IVI Roma
city: Valencia
country: Spain
facility: IVI Foundation
city: London
country: United Kingdom
facility: IVI London
Study officials:
References: