Infertility, Pregnancy, Multiple
Conditions
Brief summary
The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate
Detailed description
The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer. This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.
Interventions
PROCEDUREElective single embryo transfer
After the FIV/ICSI procedure, the embryo transfer in this arm would be of one embryo followed by the cryotransfer of one embryo in case of no conception in the fresh cycle.
PROCEDUREDouble embryo transfer
After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos
Sponsors
Instituto de Salud Carlos III
University Hospital Virgen de las Nieves
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* women less tan 38 years * women Body Mass Index (BMI) between 19-39 kg/m2 * Follicle-Stimulating Hormone (FSH) \<15 mUI/mL on cycle third day * First IVF/ICSI cycle or second after a positive pregnancy test in the first one
Exclusion criteria
* More tan five years of infertility * Previous uterus surgery * Uterus malformations * More tan one miscarriage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | Seven weeks after embryo transfer | A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Pregnancy Rate | Seven weeks after embryo transfer | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Live Birth Delivery Rate | 38 weeks after embryo transfer | The delivery of a healthy child (o two) |
Countries
Spain
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Elective Single Embryo Transfer Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception | 84 |
| Double Embryo Transfer Transfer of two fresh embryos | 91 |
| Total | 175 |
Baseline characteristics
| Characteristic | Elective Single Embryo Transfer | Total | Double Embryo Transfer |
|---|---|---|---|
| Age, Continuous | 32.2 years STANDARD_DEVIATION 3.6 | 32.0 years STANDARD_DEVIATION 3.7 | 31.7 years STANDARD_DEVIATION 3.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 84 Participants | 175 Participants | 91 Participants |
| Region of Enrollment Spain | 84 participants | 175 participants | 91 participants |
| Sex: Female, Male Female | 84 Participants | 175 Participants | 91 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 84 | 5 / 91 |
| serious Total, serious adverse events | 0 / 84 | 0 / 91 |
Outcome results
Primary
Clinical Pregnancy Rate
A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Time frame: Seven weeks after embryo transfer
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elective Single Embryo Transfer | Clinical Pregnancy Rate | 44.0 percentage of pregnancy per transfer |
| Double Embryo Transfer | Clinical Pregnancy Rate | 37.4 percentage of pregnancy per transfer |
Secondary
Multiple Pregnancy Rate
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
Time frame: Seven weeks after embryo transfer
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elective Single Embryo Transfer | Multiple Pregnancy Rate | 0 percentage of multiple pregnancies |
| Double Embryo Transfer | Multiple Pregnancy Rate | 26.4 percentage of multiple pregnancies |
Other Pre-specified
Live Birth Delivery Rate
The delivery of a healthy child (o two)
Time frame: 38 weeks after embryo transfer
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elective Single Embryo Transfer | Live Birth Delivery Rate | 45.2 percentage of live birth |
| Double Embryo Transfer | Live Birth Delivery Rate | 41.8 percentage of live birth |