Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients
NCT ID: NCT03976544
Last Updated: 2025-01-28
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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TERMINATED
PHASE4
362 participants
INTERVENTIONAL
2019-05-25
2025-01-01
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
Patients are asked to perform a blood sample, with evaluation of serum estradiol (E2), progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH), on the first or second day of the menstrual cycle. If these serum hormonal values are considered basal for the beginning of the follicular phase, patients are asked to come back on day 10 to 12 of the cycle for blood sample and transvaginal ultrasound scan in order to assess follicular growth.
The timing of ovulation is determined based on a combination of ultrasonography features (the presence of a dominant follicle and adequate endometrium) and endocrine hormonal values in serum blood samples. Ovulation is generally defined as an, at least, 180% increase of LH compared to the mean level in the previous 24h.
Frozen-warmed blastocyst transfer will take place six days following the spontaneous LH surge.
No interventions assigned to this group
Hormone replacement therapy cycle
Patients are asked to perform a blood sample, with evaluation of serum estradiol (E2), progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) on the first or second day of the menstrual cycle. If these values are considered basal for the beginning of the follicular phase, estrogen supplementation (Estradiol valerate, Progynova® 3x2mg/day) is started to induce proliferation of the endometrium. Blood sample and transvaginal ultrasound are thereafter performed ten to fourteen days later. If the endometrium is considered adequate (generally considered if triple line and above 6,5 mm thickness), embryo transfer is scheduled on the sixth day of progesterone (vaginal micronized progesterone, Utrogestan® 2x200mg twice a day) supplementation.
In case of escape spontaneous ovulation embryo transfer will be performed considering the presumable time of ovulation.
Estradiol Valerate
Estradiol valerate will be started in the beginning of the menstrual cycle in order to induce proliferation of the endometrium.
Micronized progesterone
If the endometrium is considered adequately proliferated, micronized progesterone is administered and frozen-thawed blastocyst transfer will take place on the 6th day of supplementation.
Interventions
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Estradiol Valerate
Estradiol valerate will be started in the beginning of the menstrual cycle in order to induce proliferation of the endometrium.
Micronized progesterone
If the endometrium is considered adequately proliferated, micronized progesterone is administered and frozen-thawed blastocyst transfer will take place on the 6th day of supplementation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular menstrual cycle pattern (i.e. 24-35 days cycle)
* First, second and third ICSI-PGT cycle
* First frozen embryo transfer cycle following a fresh ICSI-PGT attempt
* PGT with trophectoderm biopsy on day 5 of embryonic development
* Signed informed consent
Exclusion Criteria
* BMI above 35
* Contraindications for the use of hormonal replacement therapy
18 Years
42 Years
FEMALE
No
Sponsors
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CRG UZ Brussel
OTHER
Responsible Party
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Caroline Roelens
Clinical fellow
Locations
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Centre for Reproductive Medicine UZ Brussel
Brussels, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2018-003156-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HRT_NC-FET
Identifier Type: -
Identifier Source: org_study_id
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