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

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:
  • progesterone
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.

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

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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