NCT06128395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2024

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 7, 2023

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compare clinical pregnancy rate between patients prescribed Aspirin 81 mg vs Aspirin 162 mg

    clinical pregnancy is the presence of fetal heartbeat at the viability ultrasound

    Time Frame: 6 to 8 weeks after Frozen Embryo Transfer

Study Arms (2)

Aspirin 81 mg for Frozen Embryo Transfer (FET)

Subjects were prescribed Aspirin 81 mg to be started on the third day of their menstrual cycle in preparation for their FET.

Other: Frozen embryo transfer

Aspirin 162 mg for Frozen Embryo Transfer (FET)

Subjects were prescribed Aspirin 162 mg to be started on the third day of their menstrual cycle in preparation for their FET

Other: Frozen embryo transfer

Interventions

A frozen embryo transfer involves thawing a fertilized embryo and transferring it in the uterus in order to obtain a pregnancy

Aspirin 162 mg for Frozen Embryo Transfer (FET)Aspirin 81 mg for Frozen Embryo Transfer (FET)

Eligibility Criteria

AgeUp to 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen able to have an embryo transfered in their uterus
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

FET Data spreadsheet from January 2022 to December 2022

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Study Officials

  • Wael Jamal, MD

    Clinique Ovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

November 1, 2023

Primary Completion

August 30, 2024

Study Completion

September 18, 2024

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations