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INeS Follow-up;Medically assisted reproduction techniques: do they influence the offspring*s growth, health and neurodevelopment? Follow-up of a randomized controlled trial

INeS Follow-up;Medically assisted reproduction techniques: do they influence the offspring*s growth, health and neurodevelopment? Follow-up of a randomized controlled trial - INeS Follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43505
Enrollment
354
Registered
2016-05-31
Start date
2016-09-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovasculaire gezondheid, metabolde gezondheid, groei, neurodevelopment Cardiometabolic health neurodevelopmental health

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: The study population comprises all children born to couples who participated in the INeS-study (registered as NL12782.018.07, METC 2007_064). The INeS-study consisted of couples seeking fertility treatment after at least 12 months of unprotected intercourse. Females were between 18 and 38 years of age and had an unfavorable prognosis for natural conception (less than 30% according to the Hunault model). Couples were diagnosed with an unexplained or mild subfertility. Couples were excluded in case of polycystic ovarian syndrome (PCOS)/anovulation, endometriosis, bilateral tubal pathology or endocrine disorders. 602 Couples were randomly allocated to three cycles of IVF-SET, six cycles of IVF-MNC or six cycles of IUI-COH. ;There were 354 children born in the INeS-study: 313 singletons, 19 twins and 1 triplet. These children were born during the 12 month follow-up period (n

Exclusion criteria

Exclusion criteria: There are no exclusion criteria.

Design outcomes

Primary

MeasureTime frame
Blood pressure at age 4-6 years

Secondary

MeasureTime frame
* General health status (including physician visits, hospital admissions, medication use) * Growth trajectory * Anthropometry (including height, weight, hip-, waist- and upper arm circumference) * Body composition (including lean body mass, fat mass, total body water) * Cardiovascular health (including arterial stiffness) * Metabolic health (including glucose and insulin levels, lipid profile, inflammatory markers) * Development and behavior

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)