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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04002635
Other study ID # 2019LEFT001
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date December 1, 2020
Est. completion date April 1, 2022

Study information

Verified date January 2021
Source CRG UZ Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn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)

Study Design


Intervention

Drug:
Letrozole
Letrozole ovulation induction
estradiol valerate
hormonal replacement therapy

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
CRG UZ Brussel University Hospital, Ghent

Outcome

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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