Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer
NCT ID: NCT03642665
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
554 participants
INTERVENTIONAL
2018-09-25
2024-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Natural cycle
no medication
Natural cycle
no medication
Artificial cycle
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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…)
18 Years
45 Years
FEMALE
No
Sponsors
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GZA Ziekenhuizen Campus Sint-Augustinus
OTHER
Imelda Hospital, Bonheiden
OTHER
Jessa Hospital
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S61372
Identifier Type: -
Identifier Source: org_study_id
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