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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03642665
Other study ID # S61372
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 25, 2018
Est. completion date December 1, 2024

Study information

Verified date February 2024
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates clinical pregnancy rates, obstetrical outcome parameters, costs and patient preferences in natural cycle versus artificial cycle frozen embryo transfers (FET).


Description:

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 554
Est. completion date December 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Women undergoing FET after a first, second or third fresh IVF/ICSI cycle - Single embryo transfer (SET) or Double embryo transfer (DET) - Female age between 18-45 year - Women having a natural ovulatory cycle (24-35 days) - Normal uterine cavity (fundal indentation at the cavity <10mm) - Written informed consent Exclusion Criteria: - Use of donor gametes - BMI > or equal to 35 kg / m2 - Any contra-indication to estrogen or progesterone supplementation (e.g. history of thrombosis, prior or current hormone-sensitive malignancy…)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Natural cycle
no medication
Estradiol Valerate
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
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.

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (4)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven GZA Ziekenhuizen Campus Sint-Augustinus, Imelda Hospital, Bonheiden, Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 9 weeks
Secondary Biochemical pregnancy rate 9 weeks
Secondary Miscarriage rate 12 weeks
Secondary Ectopic pregnancy rate 9 weeks
Secondary Live birth rate 41 weeks
Secondary Multiple pregnancy rate 9 weeks
Secondary Adverse events tombo-embolic events, serious side-effects (car leaflet) which require cancellation of treatment 12 weeks
Secondary Cycle cancellation rate 4 weeks
Secondary Endometrial thickness 3 weeks
Secondary Endometrial pattern Sonographic aspect of the endometrium (triple-line, no triple-line) 3 weeks
Secondary number of center visits to monitor FET cycle From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
Secondary cost analysis per treatment cycle From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks)
Secondary 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' (a=0.81) and 'tolerability' (a=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. 12 weeks
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