Trial Outcomes & Findings for Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy. (NCT NCT03184519)

NCT ID: NCT03184519

Last Updated: 2020-08-13

Results Overview

Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

156 participants

Primary outcome timeframe

One month

Results posted on

2020-08-13

Participant Flow

Participant milestones

Participant milestones
Measure
All Patients
Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
Overall Study
STARTED
156
Overall Study
COMPLETED
129
Overall Study
NOT COMPLETED
27

Reasons for withdrawal

Reasons for withdrawal
Measure
All Patients
Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
Overall Study
Lost to Follow-up
6
Overall Study
Physician Decision
21

Baseline Characteristics

Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Patients
n=155 Participants
Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
155 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
39 years
n=5 Participants
Sex/Gender, Customized
female
155 Participants
n=5 Participants
Race/Ethnicity, Customized
hispanic/latino
2 Participants
n=5 Participants
Race/Ethnicity, Customized
not hispanic/latino
153 Participants
n=5 Participants
Race/Ethnicity, Customized
CAUCASIAN
155 Participants
n=5 Participants
Race/Ethnicity, Customized
ARAB NORTH
1 Participants
n=5 Participants
Region of Enrollment
Spain
155 Participants
n=5 Participants

PRIMARY outcome

Timeframe: One month

Population: From the 155 patients, 13 were excluded from analysis for several issues.

Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)

Outcome measures

Outcome measures
Measure
All Patients
n=142 Participants
Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Pregnancy test: Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
Number of Participants With Early Detection of Pregnancy
142 Participants

Adverse Events

All Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

LAURA CARACENA (STUDY COORDINATOR)

IVIValencia

Phone: 034 963050900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place