Pregnancy Test
Conditions
Brief summary
Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).
Interventions
DIAGNOSTIC_TESTPregnancy test
Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
Sponsors
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All the patients will undergo 3 blood samples for analyses to determine pregnancy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Patients undergoing their first or second IVF-ET cycle * Age 18-45 years * Use of Ovitrelle for final follicular maturation and luteinization * Fresh or Frozen day-5 blastocysts transrer (Autologus or Egg donation)
Exclusion criteria
* Gestational surrogacy (patient's eggs used for pregnancy in a surrogate mother) * Canceled IVF cycles * GnRH agonist triggering cycles in the case of fresh ET.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Early Detection of Pregnancy | One month | Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 155 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 21 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 155 Participants |
| Age, Continuous | 39 years |
| Race/Ethnicity, Customized ARAB NORTH | 1 Participants |
| Race/Ethnicity, Customized CAUCASIAN | 155 Participants |
| Race/Ethnicity, Customized hispanic/latino | 2 Participants |
| Race/Ethnicity, Customized not hispanic/latino | 153 Participants |
| Region of Enrollment Spain | 155 Participants |
| Sex/Gender, Customized female | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 156 |
| other Total, other adverse events | 0 / 156 |
| serious Total, serious adverse events | 0 / 156 |
Outcome results
Primary
Number of Participants With Early Detection of Pregnancy
Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)
Time frame: One month
Population: From the 155 patients, 13 were excluded from analysis for several issues.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients | Number of Participants With Early Detection of Pregnancy | 142 Participants |
p-value: 0.025t-test, 1 sided