Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

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Official title:

Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04002635
• Other study ID #: 2019LEFT001
• Status: Withdrawn
• Phase: Phase 4
• 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
• 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• Status: Withdrawn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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• IVF
• Ovulation Disorder
• Polycystic Ovary Syndrome
• Syndrome

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