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

Completed

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

Registration Number: NL-OMON43505

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 354

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<=333) or somewhat thereafter (n<=9).

Exclusion Criteria

There are no exclusion criteria.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Blood pressure at age 4-6 years</p><br>

Secondary Outcome Measures

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