- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002635
Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS) (LEFT)
January 6, 2021 updated by: Liese Boudry, CRG UZ Brussel
Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
hormonal replacement therapy
Other Names:
|
Experimental: Letrozole
Using letrozole for ovulation induction before planning the frozen embryo transfer
|
Letrozole ovulation induction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
early pregnancy loss
Time Frame: 12 weeks after frozen embryo transfer
|
12 weeks after frozen embryo transfer
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cancellation rate
Time Frame: 2 months
|
2 months
|
number of visits to the clinic
Time Frame: 2 months
|
2 months
|
endometrial thickness on the day of planning of FET
Time Frame: 1 day
|
1 day
|
implantation rate
Time Frame: 1 day
|
1 day
|
biochemical and clinical pregnancy rate
Time Frame: 12 weeks
|
12 weeks
|
live birth rate
Time Frame: 1 year
|
1 year
|
neonatal birth weight
Time Frame: 1 year
|
1 year
|
term of delivery
Time Frame: 1 year
|
1 year
|
hypertensive disorders of pregnancy
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2020
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
June 27, 2019
First Submitted That Met QC Criteria
June 27, 2019
First Posted (Actual)
June 28, 2019
Study Record Updates
Last Update Posted (Actual)
January 8, 2021
Last Update Submitted That Met QC Criteria
January 6, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Polycystic Ovary Syndrome
- Syndrome
- Infertility
- Infertility, Female
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Progestins
- Letrozole
- Estradiol
- Progesterone
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- 2019LEFT001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Sharing with other study site, UZ Gent
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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