OPTIMisation of cost effectiveness through Individualised FSH Stimulation dosages for IVF Treatment: A randomised trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27790

Enrollment

1500

Registered

2010-12-20

Start date

2011-05-01

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

IVF/ICSI Infertility Ovarian reserve test Antral follicle count (AFC) Individualized FSH regimen

Interventions

Patients with predicted poor response (AFC below 101) on the ORT will be randomly allocated to a treatment strategy based on an increased FSH dose versus standard FSH dose. In case they are randomised

Eligibility

Inclusion criteria

Inclusion criteria: 1. Regular indication for IVF or IVF-ICSI; 2. Female age < 44 years; 3. Regular cycle (average length 25-35 days); 4. No major uterine or ovarian abnormalities detected at TVS; 5. No previous IVF cycles; 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Oocyte donation; 2. Medical contra indication for pregnancy or IVF treatment; 3. Polycystic Ovary Syndrome (PCOS); 4. Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney).

Design outcomes

Primary

Measure	Time frame
1. Ongoing pregnancy resulting in live birth within 18 months after randomisation. These pregnancies can be obtained in treatment cycles with fresh embryos, as well as in SUBSEQUENT CRYO/THAW CYCLES after completion of any fresh stimulation cycle. Spontaneous pregnancies between treatment cycles will also be taken into account; 2. Costs of treatment: Direct medical costs, direct non-medical costs and indirect costs.	—

Measure

Time frame

1. Ongoing pregnancy resulting in live birth within 18 months after randomisation. These pregnancies can be obtained in treatment cycles with fresh embryos, as well as in SUBSEQUENT CRYO/THAW CYCLES after completion of any fresh stimulation cycle. Spontaneous pregnancies between treatment cycles will also be taken into account; 2. Costs of treatment: Direct medical costs, direct non-medical costs and indirect costs.

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Secondary

Measure	Time frame
1. Number of oocytes; 2. Poor response (less than 5 oocytes at retrieval or cancellation due to insufficient follicle growth, i.e. less than 2 dominant follicles sized more than 12 mm growing); 3. Hyper response (more than 15 oocytes at retrieval or cancellation due to excessive response, i.e. > 20 follicles sized > 12 mm with an estradiol above 11.700 pmol/L OR > 30 follicles sized > 12 mm growing); 4. OHSS grade 2 or 3; 5. Cycle cancellation for hyper and poor response, multiple pregnancy, total IU of FSH applied per stimulation cycle, number of cycles needed per live birth, prevalence of abnormal ORT in subfertile women.	—

Measure

Time frame

1. Number of oocytes; 2. Poor response (less than 5 oocytes at retrieval or cancellation due to insufficient follicle growth, i.e. less than 2 dominant follicles sized more than 12 mm growing); 3. Hyper response (more than 15 oocytes at retrieval or cancellation due to excessive response, i.e. > 20 follicles sized > 12 mm with an estradiol above 11.700 pmol/L OR > 30 follicles sized > 12 mm growing); 4. OHSS grade 2 or 3; 5. Cycle cancellation for hyper and poor response, multiple pregnancy, total IU of FSH applied per stimulation cycle, number of cycles needed per live birth, prevalence of abnormal ORT in subfertile women.

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Contacts

Public ContactF.J. Broekmans

Heidelberglaan 100

f.broekmans@umcutrecht.nl+31 (0)88 7551041

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)