Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients.

NCT05168865 | Withdrawn Phase 4

• 1 other identifier: DSREC-09/2020_16
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

One of the indications of freezing is to reduce the risk of ovarian hyperstimulation syndrome particularly in polycystic ovarian disease (PCOS) women. Very few RCTs addressed the issue of optimizing the endometrium for a frozen cycle. Interestingly, Letrozole for ovarian stimulation showed significantly better reproductive outcome when compared with hormone replacement therapy (HRT) cycle. In addition, HRT cycle has been associated with higher miscarriage rate when compared with natural cycle frozen embryo transfer. Nevertheless, there is not yet a well-designed prospective randomized study comparing letrozole and HRT in PCOS women undergoing frozen embryo transfer.

Conditions

Frozen Embryo Transfer; Polycystic Ovarian Disease; Letrozole; Hormone Replacement Therapy; Live Birth; Miscarriage

Outcome Measures

Primary Outcomes (1)

• livebirth rate per embryo transfer

  A birth after 24 weeks gestation with a baby showing signs of life.

  9 months

Secondary Outcomes (2)

• miscarriage rate per embryo transfer

  6 months

• ongoing pregnancy per embryo transfer

  3 months

Study Arms (2)

PCOS women will receive letrozole ovarian stimulation.

EXPERIMENTAL

Polycystic ovarian disease (PCOS) women undergoing frozen embryo transfer (FER) will use Letrozole 5 mg starting on day 3 of spontaneous menstrual period or after progesterone withdrawal bleeding for five consecutive days.

Drug: Letrozole 2.5mg

PCOS women will receive Estradiol and Progesterone (hormonal endometrial preparation).

ACTIVE COMPARATOR

PCOS women will use daily Cetorelix acetate 0.25 mg injections for 5 days from day 1-3 of the menstrual follow or after progesterone (P4) withdrawal bleeding. They will commence daily oral Estradiol Valerate (E2) 2 mg twice daily for 5 days starting from day 3 of the menstrual flow or after P4 withdrawal bleeding, then-after three times daily. When endometrial thickness reaches 7 mm or more, the dose of E2 will be reduced to 4 mg/ day. Women will start using vaginal micronized P4 100 mg three times daily starting from 8PM. After 48 hours of starting the vaginal P4, oral Dydrogesterone 10 mg three times daily will commence.

Drug: Letrozole 2.5mg

Interventions

Letrozole 2.5mg DRUG

Letrozole 5 mg starting on day 3 of spontaneous menstrual period or after progesterone withdrawal bleeding for five consecutive days.

Also known as: estradiol and progesterone

PCOS women will receive Estradiol and Progesterone (hormonal endometrial preparation).; PCOS women will receive letrozole ovarian stimulation.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with PCOS diagnosed with Rotterdam criteria.
• Age between 20 to 40-year-old
• Undergoing frozen oocytes intracytoplasmic sperm injection transfer or frozen embryo transfer
• Willingly accept to participate in the study

You may not qualify if:

• Women \> 40 years old or younger than 20.
• Uterine pathology that decreases the chance of pregnancy or increases risk of miscarriage such as
• Uterine fibroids (sub-mucous of any size or intramural of \> 3 cm)
• Uncontrolled endocrinal-pathological disease like
• Cushing syndrome,
• Adrenal hyperplasia,
• Hyperprolactinemia,
• Acromegaly,
• Thyroid disease,
• Diabetes mellitus, and
• Immune disorders.
• Presence of Hydrosalpinx
• Not willing or able to sign the consent form.

Sponsors & Collaborators

• Dubai Fertility Center: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Abortion, Spontaneous

Interventions

Letrozole; Estradiol; Progesterone

Condition Hierarchy (Ancestors)

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

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: Principal investigator

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 23, 2021
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02