This study evaluates clinical pregnancy rates, obstetrical outcome parameters, costs and patient preferences in natural cycle versus artificial cycle frozen embryo transfers (FET).
Transfer of cryopreserved embryos can be performed in a natural cycle (NC-FET) or in an artificially prepared cycle (AC-FET). Both cycle regimens have their advantages and disadvantages. So far, most comparative studies have failed to identify the optimal protocol for FET. In this study patients undergoing FET will be randomized between an endometrial preparation by a natural cycle or by an artificial cycle (by oestradiol validate and micronized progesterone).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
554
no medication
Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
UZ Leuven
Leuven, Belgium
Clinical pregnancy rate with fetal heart beat
Clinical pregnancy rate with fetal heart beat diagnosed by ultrasound no later than the gestational age of 9 weeks
Time frame: 9 weeks
Biochemical pregnancy rate
Time frame: 9 weeks
Miscarriage rate
Time frame: 12 weeks
Ectopic pregnancy rate
Time frame: 9 weeks
Live birth rate
Time frame: 41 weeks
Multiple pregnancy rate
Time frame: 9 weeks
Adverse events
tombo-embolic events, serious side-effects (car leaflet) which require cancellation of treatment
Time frame: 12 weeks
Cycle cancellation rate
Time frame: 4 weeks
Endometrial thickness
Time frame: 3 weeks
Endometrial pattern
Sonographic aspect of the endometrium (triple-line, no triple-line)
Time frame: 3 weeks
number of center visits to monitor FET cycle
Time frame: From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
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cost analysis per treatment cycle
Time frame: From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
patient satisfaction
To evaluate the effect of the different regimens on patients wellbeing/distress, Patient Reported Experience Measures (PREMS) from validated questionnaires will be used. Twenty-two questions from the Benyamini questionnaire will be used (Benyamini et al. 2005) and 10 questions from the subscales 'environment' (α=0.81) and 'tolerability' (α=0.75) of the FertilQol questionnaire (Pedro et al 2013). On the day of embryo transfer, the treating gynecologist will hand out the questionnaire to the patient. The patient will return the filled-in questionnaire on the day of the pregnancy test, before she knows the result of the pregnancy test.
Time frame: 12 weeks