Euploid Embryos, Frozen Embryo Transfer, Hormone Replacement Therapy Cycle, Miscarriage, Natural Cycle, Preimplantation Genetic Screening
Conditions
Keywords
frozen-thawed embryo transfer, FET, natural cycle, hormone replacement therapy cycle, miscarriage
Brief summary
The aim of the current study is to compare miscarriage rates (before 8 weeks) between a true natural cycle (awaiting spontaneous LH surge) and a hormone replacement therapy cycle prior to blastocyst transfer in preimplantation genetic testing (PGT) patients, with biopsy on day 5 of embryonic development. The advantage of performing the study in PGT patients is the exclusion of aneuploidy as a cause of miscarriage.
Interventions
DRUGEstradiol Valerate
Estradiol valerate will be started in the beginning of the menstrual cycle in order to induce proliferation of the endometrium.
DRUGMicronized 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.
Sponsors
CRG UZ Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to either natural cycle frozen-thawed embryo transfer (group A), or hormonal replacement therapy cycle frozen-thawed embryo transfer (group B).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* BMI under 35 kg/m2 * 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
* Oligo-amenorrhea * BMI above 35 * Contraindications for the use of hormonal replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage rate before 8 weeks of gestation | 8 weeks | a spontaneous loss of a clinical pregnancy before 8 weeks of gestational age, in which the embryo(s) is/are nonviable and is/are (not) spontaneously absorbed or expelled from the uterus per initiated embryo transfer cycle and per positive hCG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage rate after 8 weeks of gestation | 22 weeks | a spontaneous loss of a clinical pregnancy after 8 weeks but before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus per initiated embryo transfer cycle and per positive hCG |
| Clinical pregnancy rate | 7 weeks | a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy per initiated embryo transfer cycles |
| Ongoing pregnancy rate | 20 weeks | the number of pregnancies after 20 weeks of gestation per initiated embryo transfer cycle |
Countries
Belgium
Outcome results
None listed