ASA 81 mg vs 162 mg During Frozen Embryo Transfer (FET)

Active, not recruiting

• Conditions: Fertility Disorders
• Interventions: Other: Frozen embryo transfer

• Registration Number: NCT06128395
• Lead Sponsor: Clinique Ovo

Brief Summary

The use of low dose aspirin is recommended for high risk patients to reduce the risk of pre-eclampsia, placental abruption and antepartum hemorrhage. Recent studies have shown that in a specific population, the use of low dose aspirin might reduce the risk of preterm birth in pregnant women with singleton pregnancy. In June 2022, clinique ovo started implementing the use of Aspirin 162 mg instead of 81 mg in the frozen embryo transfer cycles based on recent study outcomes. The use of Aspirin 162 mg might have additional benefits on the embryo transfer outcomes by decreasing the miscarriage. Moreover this can be continued until late in pregnancy without adverse effects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-01
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-08-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Women taking aspirin 81 mg or 162 mg prior to an autologous embryo transfer
• Age < 40 years old
• Embryo transfer cycle done at clinique ovo

Exclusion Criteria

• Egg or embryo recipient
• History of recurrent miscarriages, defined as ≥ 3 consecutive losses
• Patients that needed Viagra, PRP or other modalities to improve their endometrial thickness
• Uterine factor infertility
• Abnormal hormonal profiles
• Stimulated embryo transfer cycles
• History of recurrent implantation failure defined as failed ≥ 2 euploid embryos transfer or ≥ 3 blastocysts

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aspirin 81 mg for Frozen Embryo Transfer (FET)	Frozen embryo transfer	Subjects were prescribed Aspirin 81 mg to be started on the third day of their menstrual cycle in preparation for their FET.
Aspirin 162 mg for Frozen Embryo Transfer (FET)	Frozen embryo transfer	Subjects were prescribed Aspirin 162 mg to be started on the third day of their menstrual cycle in preparation for their FET

Primary Outcome Measures

Name	Time	Method
Compare clinical pregnancy rate between patients prescribed Aspirin 81 mg vs Aspirin 162 mg	Time Frame: 6 to 8 weeks after Frozen Embryo Transfer	clinical pregnancy is the presence of fetal heartbeat at the viability ultrasound

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada