NCT04544462

Brief Summary

This study aims to characterize the association between history of pregnancy complications and M2 carrier status in IVF patients and the utility of M2 haplotype preimplantation genetic testing (PGT) in embryos produced by carrier couples. Participants in this study will be screened for the M2 variant. History of pregnancy complications and miscarriages will be studied in order to determine potential associations with M2 carrier-ship.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress92%
Feb 2020Dec 2026

Study Start

First participant enrolled

February 10, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

6.7 years

First QC Date

September 3, 2020

Last Update Submit

August 19, 2025

Conditions

InfertilityMiscarriage, RecurrentPregnancy Complications

Outcome Measures

Primary Outcomes (1)

  • M2 Haplotype frequency

    Frequency of carriers of the M2 haplotype attending an IVF center for infertility treatment.

    1 month

Study Arms (1)

Infertile patients

Patients attending an IVF center for infertility treatment

Other: M2 Test

Interventions

M2 TestOTHER

DNA will be extracted from saliva samples obtained from participants. Genetic testing will be performed to screen for the M2 mutation and determine the carrier status of each patient and partner.

Infertile patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All couples above the age of 18 seeking infertility treatment at IVF centers

You may qualify if:

  • All couples above the age of 18

You may not qualify if:

  • Any case where biological parental DNA is unavailable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genomic Prediction Clinical Laboratory

North Brunswick, New Jersey, 08902, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva swabs will be collected from participants. DNA will be extracted and used to screen for the M2 haplotype.

MeSH Terms

Conditions

InfertilityAbortion, HabitualPregnancy Complications

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesAbortion, SpontaneousFemale Urogenital Diseases and Pregnancy Complications

Study Design

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

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 10, 2020

Study Start

February 10, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)