Infertility, Female, IVF, Ovulation Disorder, Polycystic Ovary Syndrome
Conditions
Keywords
frozen embryo transfer
Brief summary
To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.
Interventions
DRUGLetrozole
Letrozole ovulation induction
DRUGestradiol valerate
hormonal replacement therapy
Sponsors
University Hospital, Ghent
CRG UZ Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age more than or equal to 18 and less than or equal to 40 * BMI more than or equal to 18 and less than or equal to 35 * Diagnosis of PCOS according to Rotterdam criteria * Normal gynaecological ultrasound \< 6 months before inclusion * Signed informed consent form * Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage
Exclusion criteria
* Recurrent implantation failure * Recurrent miscarriage * Presence of adenomyosis * Untreated intrauterine pathology * rAFS (revised American Fertility Society) Grade III or IV endometriosis * Hydrosalpinx * In vitro maturation (IVM) * Untreated autoimmune disorders * (History of) malignancy * Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past * Pre-implantation genetic testing (PGT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| early pregnancy loss | 12 weeks after frozen embryo transfer |
Secondary
| Measure | Time frame |
|---|---|
| number of visits to the clinic | 2 months |
| endometrial thickness on the day of planning of FET | 1 day |
| implantation rate | 1 day |
| biochemical and clinical pregnancy rate | 12 weeks |
| cancellation rate | 2 months |
| neonatal birth weight | 1 year |
| term of delivery | 1 year |
| hypertensive disorders of pregnancy | 1 year |
| live birth rate | 1 year |
Outcome results
None listed