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

Phase 4

Withdrawn

• Conditions: Infertility, Female; Polycystic Ovary Syndrome; IVF; Ovulation Disorder
• Interventions: Drug: estradiol valerate; Drug: Letrozole

• Registration Number: NCT04002635
• Lead Sponsor: CRG UZ Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Study Start: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-08
• Primary Completion: 2021-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hormonal Replacement Therapy	estradiol valerate	Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.
Letrozole	Letrozole	Using letrozole for ovulation induction before planning the frozen embryo transfer

Primary Outcome Measures

Name	Time	Method
early pregnancy loss	12 weeks after frozen embryo transfer

Secondary Outcome Measures

Name	Time	Method
cancellation rate	2 months
endometrial thickness on the day of planning of FET	1 day
neonatal birth weight	1 year
term of delivery	1 year
number of visits to the clinic	2 months
implantation rate	1 day
biochemical and clinical pregnancy rate	12 weeks
live birth rate	1 year
hypertensive disorders of pregnancy	1 year