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

NCT04002635 | Withdrawn Phase 4 DMC

• 1 other identifier: 2019LEFT001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

frozen embryo transfer

Outcome Measures

Primary Outcomes (1)

• early pregnancy loss

  12 weeks after frozen embryo transfer

Secondary Outcomes (9)

• 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

Study Arms (2)

Hormonal Replacement Therapy

ACTIVE COMPARATOR

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

Drug: estradiol valerate

Letrozole

EXPERIMENTAL

Using letrozole for ovulation induction before planning the frozen embryo transfer

Drug: Letrozole

Interventions

Letrozole DRUG

Letrozole ovulation induction

Letrozole

estradiol valerate DRUG

hormonal replacement therapy

Also known as: progesterone

Hormonal Replacement Therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Signed informed consent form
• Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage

You may not qualify if:

• 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)

Sponsors & Collaborators

• CRG UZ Brussel: lead
• University Hospital, Ghent: collaborator

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome

Interventions

Letrozole; Estradiol; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: June 28, 2019
• Study Start: December 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE