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

Comparing in vitro maturation of oocytes with in vitro fertilisation in women with an increased risk of ovarian hyperstimulation syndrome: A multicentre randomised controlled trial with non-randomised pilot study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24086

Enrollment

450

Registered

2010-06-17

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Infertility, PCOS, OHSS

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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); 2. 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: 1. Woman or partner younger than 18 years and woman older than 38 years; 2. Unable to speak or read the Dutch language; 3. Medical contraindication for pregnancy or childbirth; 4. Positive serology for Hepatitis B, C or HIV; 5. 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; 6. Persisting ovarian cysts > 30 mm diameter.

Design outcomes

Primary

Measure	Time frame
Cumulative live birth rate after IVM/ICSI or COH/IVF/ICSI strategy including pregnancies from cryoembryos transferred within 12 months after the end of IVM/ICSI or COH/IVF/ICSI treatment.	—

Secondary

Measure	Time frame
1. Health and development of IVM/ICSI children versus COH/IVF/ICSI children in a 5 years’ follow up program; 2. Number and nature of adverse events during or following the two treatment strategies, specifically including OHSS and multiple pregnancies; 3. Direct and indirect costs of the two treatment strategies; 4. Patients’ quality of life scores as derived from validated questionnaires.	—

Contacts

Public ContactJ.P. Bruin, de

Postbus 90153

j.d.bruin@jbz.nl+31 (0)73 6998660

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)