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

Sponsor

CRG UZ Brussel (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04002635

Collaborator

University Hospital, Ghent (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Polycystic Ovary Syndrome IVF Ovulation Disorder	Drug: Letrozole Drug: estradiol valerate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hormonal Replacement Therapy Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.	Drug: estradiol valerate hormonal replacement therapy Other Names: progesterone
Experimental: Letrozole Using letrozole for ovulation induction before planning the frozen embryo transfer	Drug: Letrozole Letrozole ovulation induction

Arm

Intervention/Treatment

Active Comparator: Hormonal Replacement Therapy

Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.

Drug: estradiol valerate

hormonal replacement therapy

Other Names:

progesterone

Experimental: Letrozole

Using letrozole for ovulation induction before planning the frozen embryo transfer

Drug: Letrozole

Letrozole ovulation induction

Outcome Measures

Primary Outcome Measures

early pregnancy loss [12 weeks after frozen embryo transfer]

Secondary Outcome Measures

cancellation rate [2 months]
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]
live birth rate [1 year]
neonatal birth weight [1 year]
term of delivery [1 year]
hypertensive disorders of pregnancy [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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)