No registrations found.
ID
Source
Brief title
Health condition
EN: subfertility, cryo thawed embryo transfer, IVF
NL: subfertiliteit, gecryopreserveerder embryo's, IVF
Sponsors and support
dr. BJ Cohlen & drs. ER Groenewoud
Postbus 10400
8000 GK Zwolle
Intervention
Outcome measures
Primary outcome
Live birth rate.
Secondary outcome
1. Clinical pregnancy, ongoing pregnancy, cancellation rates (per started cryo cycle).
2. Endometrial growth.
3. Cost efficiancy and analyses of the burden of treatment.
4. SAE.
Background summary
Cryopreservation of embryos derived from IVF or IVF-ICSI treatment is a save and cost efficient supplement to regular IVF treatment. Before transferring the embryo’s into the uterus it’s necessary to synchronise development of embryo and endometrium. This synchronisation is essential for the success of the treatment. Because of this need cryo embryo transfer needs planning en preparation. The are several methods of endometrial preparation preceding frozen thawed embryo transfer. Most common are natural cycle and artificial cycle preparation. Both are accepted methods of endometrium preparation and it’s common opinion that live birth rates are comparable. Despite this claim so far no randomised study has been undertaken to confirm this statement.
Study objective
To compare live birth rates among patients receiving cryo thawed embryo transfer after endometrial preparation with estrogen/progesterone substitution and patients receiving cryo thawed embryo transfer in a natural cycle.
Study design
No interim analysis will be performed. Total duration of the study will be 3 years (+ 9 months follow up of pregnant subjects).
Intervention
Cryo thawed embryo transfer in natural cycle versus artificial cycle.
Inclusion criteria
1. Patients between 18 en 40, planning to receive a frozen thawed embryo transfer, embryos orginated out of IVF/ICSI treatment 1,2 or 3.
2. Patients are willing to participate during 1 frozen thawed embryo transfer treatment cycle and are willing to sign informed consent.
3. Ovulatoir menstruationcycle between 26 and 35 days.
Exclusion criteria
Patients with a contraindication for medication used in this study such as:
1. Trombo-embolic event in the patients history;
2. Severe disorder of liverfunction;
3. Estrogen sensitive tumors;
4. Breastcancer;
5. Porfyria;
6. Patients with a known allergy for one of the used medicines;
7. Patients with anovulatory menstruation cycles;
8. Patients with uterine abnormalities;
9. Patients with cryo embryos derrived from oocyte donation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1515 |
| NTR-old | NTR1586 |
| Other | ABR/eudraCT : 23273/2008-002689-68 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |