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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Letrozole
* Drug: estradiol valerate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early pregnancy loss |  | 12 weeks after frozen embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frozen embryo transfer