Polycystic Ovary Syndrome Clinical Trial
— LEFTOfficial title:
Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
Verified date | January 2021 |
Source | CRG UZ Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
CRG UZ Brussel | University Hospital, Ghent |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | early pregnancy loss | 12 weeks after frozen embryo transfer | ||
Secondary | cancellation rate | 2 months | ||
Secondary | number of visits to the clinic | 2 months | ||
Secondary | endometrial thickness on the day of planning of FET | 1 day | ||
Secondary | implantation rate | 1 day | ||
Secondary | biochemical and clinical pregnancy rate | 12 weeks | ||
Secondary | live birth rate | 1 year | ||
Secondary | neonatal birth weight | 1 year | ||
Secondary | term of delivery | 1 year | ||
Secondary | hypertensive disorders of pregnancy | 1 year |
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