A randomised controlled trial comparing in vitro maturation of oocytes with in vitro fertilisation in women with an increased risk of ovarian hyperstimulation syndrome.

A randomised controlled trial comparing in vitro maturation of oocytes with in vitro fertilisation in women with an increased risk of ovarian hyperstimulation syndrome. - IVM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33044

Enrollment

450

Registered

2009-12-03

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

subfertility unvoluntary childlessness

Interventions

2 IVM/ICSI cycles or 1 COH/IVF or COH/ICSI cycle.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Women with PCOS according to the Rotterdam Criteria (The Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group, 2004) which not did achieve an ongoing pregnancy after ovulation induction (with clomiphene citrate or LEO and rFSH) - Women with an IVF or ICSI indication and increased risk for developing OHSS (history of OHSS or cycle cancellation for imminent OHSS)

Exclusion criteria

Exclusion criteria: - Woman or partner younger than 18 years and woman older than 38 years - Unable to speak or read the Dutch language - Medical contraindication for pregnancy or childbirth - Positive serology for Hepatitis B, C or HIV (conform: Standpunt inzake screening op infectieziekten bij kunstmatig geassisteerde voortplanting, www.embryologen.nl). - Diminished ovarian reserve: early follicular serum FSH > 10 IU/l and/or poor response during earlier COH/IVF or COH/ICSI with ³ 150 IU rFSH/day (definition poor response: cycle cancellation in growth of 30 mm diameter.

Design outcomes

Primary

Measure	Time frame
Cumulative live birth rate after IVM/ICSI or COH/IVF/ICSI strategy.	—

Secondary

Measure	Time frame
- Health and development of IVM/ICSI children versus COH/IVF/ICSI children in a 5 years* follow up program - Number and nature of adverse events during or following the two treatment strategies, specifically including OHSS and multiple pregnancies. - Direct and indirect costs of the two treatment strategies. - Patients* quality of life scores as derived from validated questionnaires.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)