4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS) (LEFT)

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

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 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 Name: progesterone
Experimental: Letrozole
Using letrozole for ovulation induction before planning the frozen embryo transfer
 Drug: Letrozole
Letrozole ovulation induction
Outcome Measures
Primary Outcome Measures :
  1. early pregnancy loss [ Time Frame: 12 weeks after frozen embryo transfer ]

Secondary Outcome Measures :
  1. cancellation rate [ Time Frame: 2 months ]
  2. number of visits to the clinic [ Time Frame: 2 months ]
  3. endometrial thickness on the day of planning of FET [ Time Frame: 1 day ]
  4. implantation rate [ Time Frame: 1 day ]
  5. biochemical and clinical pregnancy rate [ Time Frame: 12 weeks ]
  6. live birth rate [ Time Frame: 1 year ]
  7. neonatal birth weight [ Time Frame: 1 year ]
  8. term of delivery [ Time Frame: 1 year ]
  9. hypertensive disorders of pregnancy [ Time Frame: 1 year ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date January 8, 2021
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019) 		early pregnancy loss [ Time Frame: 12 weeks after frozen embryo transfer ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • cancellation rate [ Time Frame: 2 months ]
  • number of visits to the clinic [ Time Frame: 2 months ]
  • endometrial thickness on the day of planning of FET [ Time Frame: 1 day ]
  • implantation rate [ Time Frame: 1 day ]
  • biochemical and clinical pregnancy rate [ Time Frame: 12 weeks ]
  • live birth rate [ Time Frame: 1 year ]
  • neonatal birth weight [ Time Frame: 1 year ]
  • term of delivery [ Time Frame: 1 year ]
  • hypertensive disorders of pregnancy [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)
Official Title  ICMJE Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infertility, Female
  • Polycystic Ovary Syndrome
  • IVF
  • Ovulation Disorder
Intervention  ICMJE
  • Drug: Letrozole
    Letrozole ovulation induction
  • Drug: estradiol valerate
    hormonal replacement therapy
    Other Name: progesterone
Study Arms  ICMJE
  • Active Comparator: Hormonal Replacement Therapy
    Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.
    Intervention: Drug: estradiol valerate
  • Experimental: Letrozole
    Using letrozole for ovulation induction before planning the frozen embryo transfer
    Intervention: Drug: Letrozole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 6, 2021) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2019) 		242
Estimated Study Completion Date  ICMJE April 1, 2022
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002635
Other Study ID Numbers  ICMJE 2019LEFT001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Sharing with other study site, UZ Gent
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Liese Boudry, CRG UZ Brussel
Study Sponsor  ICMJE CRG UZ Brussel
Collaborators  ICMJE University Hospital, Ghent
Investigators  ICMJE Not Provided
PRS Account CRG UZ Brussel
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯