Trial Outcomes & Findings for eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer (NCT NCT01909570)
NCT ID: NCT01909570
Last Updated: 2024-05-16
Results Overview
A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
COMPLETED
NA
194 participants
Seven weeks after embryo transfer
2024-05-16
Participant Flow
The recruitment period was from January 2010 to December 2012. The location of the recruitment was University Hospital of Virgen de las Nieves in Granada.
A total of 194 women aged under 38 years were included in the study. Of these, 19 women were not randomised. The reasons were refusion to participate (n= 6), economic reasons (n = 2), participating in another study (n= 7) and not meeting criteria in further evaluation (n = 4).
Participant milestones
| Measure |
Elective Single Embryo Transfer
Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
|
Double Embryo Transfer
Transfer of two fresh embryos
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
91
|
|
Overall Study
COMPLETED
|
57
|
64
|
|
Overall Study
NOT COMPLETED
|
27
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer
Baseline characteristics by cohort
| Measure |
Elective Single Embryo Transfer
n=84 Participants
Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
|
Double Embryo Transfer
n=91 Participants
Transfer of two fresh embryos
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
32.0 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
84 participants
n=5 Participants
|
91 participants
n=7 Participants
|
175 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Seven weeks after embryo transferPopulation: Women aged under 38 years, with BMI between 19-29 kg/m2, FSH \<15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.
A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Outcome measures
| Measure |
Elective Single Embryo Transfer
n=84 Participants
Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
|
Double Embryo Transfer
n=91 Participants
Transfer of two fresh embryos
|
|---|---|---|
|
Clinical Pregnancy Rate
|
44.0 percentage of pregnancy per transfer
|
37.4 percentage of pregnancy per transfer
|
SECONDARY outcome
Timeframe: Seven weeks after embryo transferPopulation: Women aged under 38 years, with BMI between 19-29 kg/m2, FSH \<15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.
A multiple clinical pregnancy was defined by the presence of more than one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Outcome measures
| Measure |
Elective Single Embryo Transfer
n=84 Participants
Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
|
Double Embryo Transfer
n=91 Participants
Transfer of two fresh embryos
|
|---|---|---|
|
Multiple Pregnancy Rate
|
0 percentage of multiple pregnancies
|
26.4 percentage of multiple pregnancies
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 38 weeks after embryo transferPopulation: Women aged under 38 years, with BMI between 19-29 kg/m2, FSH \<15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.
The delivery of a healthy child (o two)
Outcome measures
| Measure |
Elective Single Embryo Transfer
n=84 Participants
Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
|
Double Embryo Transfer
n=91 Participants
Transfer of two fresh embryos
|
|---|---|---|
|
Live Birth Delivery Rate
|
45.2 percentage of live birth
|
41.8 percentage of live birth
|
Adverse Events
Elective Single Embryo Transfer
Double Embryo Transfer
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Elective Single Embryo Transfer
n=84 participants at risk
Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
|
Double Embryo Transfer
n=91 participants at risk
Transfer of two fresh embryos
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
premature birth
|
3.6%
3/84 • Number of events 3
|
3.3%
3/91 • Number of events 3
|
|
Reproductive system and breast disorders
Hiperstimulation Ovarian Syndrome
|
0.00%
0/84
|
2.2%
2/91 • Number of events 2
|
Additional Information
Dr. Ana Clavero
University Hospital Virgen de las Nieves
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place