A multicentre 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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61229302

Enrollment

450

Registered

2010-05-27

Start date

2010-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Infertility

Interventions

Patients will be randomised to: 1. IVM/ICSI strategy 1.1. The maximum number of IVM cycles per patient is two. 1.2. The IVM cycle will be sonographically and endocrinologically monitored (serum estr

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with Polycystic Ovarian Syndrome (PCOS) according to the Rotterdam Criteria (The Rotterdam European Society of Human Reproduction and Embryology [ESHRE] /American Society for Reproductive Medicine [ASRM] - Sponsored PCOS consensus workshop group, 2004) which not did achieve an ongoing pregnancy after ovulation induction (with clomiphene citrate or Laparoscopic Electrocoagulation of the Ovaries (LEO) and Recombinant Follicle Stimulating Hormone [rFSH]) 2. Women with an IVF or ICSI indication and increased risk for developing Ovarian Hyperstimulation Syndrome (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 = 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. Pregnancy/Childbirth: Detailed information on maternal complications will be obtained from the obstetrician treating the woman concerned. Six weeks after the expected day of delivery all women will be contacted by telephone to ask information on the delivery and on the health of the child, and for consent to contact the health centre where she gave birth. If a child has been hospitalised the paediatrician treating the child will be contacted for further information. 2. Paediatric follow up: Follow up will consist of evaluation on the following domains using internationally accredited and validated tests: motor development, cognitive development, and behaviour. Follow up visits will be scheduled at ages of 6 months, 1, 2, and 5 years. 3. Economic evaluation: A distinction will be made between costs of medical interventions (direct costs) and costs resulting from productivity losses (indirect or time costs). Standardised unit costs will be calculated for all centres based on actual expenses made during the study. Subsequently, unit costs will be applied to resource use as observed in the participating centres. Resource utilisation will be documented using individual patient data in the case record forms. In addition, each woman will receive a questionnaire for details on associated direct costs of professional care, and on indirect costs like transportation and productivity loss. These questionnaires will be sent 4 weeks, 12 weeks, 24 weeks and 48 weeks after treatment start. Resource unit prices will reflect the unit of staff, materials, equipment, housing, depreciation, and overhead. End point for cost-effectiveness will be Euros/live-birth for either strategy. 4. Patient quality of life study: Before starting a treatment cycle, the day before oocyte retrieval and the day after oocyte retrieval and 3 weeks after a treatment cycle patients will be asked to fill out a validated questionnaire on quality of life (Fertiqol questionnaire, www.fertiqol.org).	—

Measure

Time frame

1. Pregnancy/Childbirth: Detailed information on maternal complications will be obtained from the obstetrician treating the woman concerned. Six weeks after the expected day of delivery all women will be contacted by telephone to ask information on the delivery and on the health of the child, and for consent to contact the health centre where she gave birth. If a child has been hospitalised the paediatrician treating the child will be contacted for further information. 2. Paediatric follow up: Follow up will consist of evaluation on the following domains using internationally accredited and validated tests: motor development, cognitive development, and behaviour. Follow up visits will be scheduled at ages of 6 months, 1, 2, and 5 years. 3. Economic evaluation: A distinction will be made between costs of medical interventions (direct costs) and costs resulting from productivity losses (indirect or time costs). Standardised unit costs will be calculated for all centres based on actual expenses made during the study. Subsequently, unit costs will be applied to resource use as observed in the participating centres. Resource utilisation will be documented using individual patient data in the case record forms. In addition, each woman will receive a questionnaire for details on associated direct costs of professional care, and on indirect costs like transportation and productivity loss. These questionnaires will be sent 4 weeks, 12 weeks, 24 weeks and 48 weeks after treatment start. Resource unit prices will reflect the unit of staff, materials, equipment, housing, depreciation, and overhead. End point for cost-effectiveness will be Euros/live-birth for either strategy. 4. Patient quality of life study: Before starting a treatment cycle, the day before oocyte retrieval and the day after oocyte retrieval and 3 weeks after a treatment cycle patients will be asked to fill out a validated questionnaire on quality of life (Fertiqol questionnaire, www.fertiqol.org).

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026