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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective single embryo transfer | Experimental | After the FIV/ICSI procedure, in this arm the embryo transfer would be of a single embryo followed by the cryotransfer or a single embryo in case of no fresh conception |
|
| Double embryo transfer | Active Comparator | After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective single embryo transfer | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Seven weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Seven weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth Delivery Rate | The delivery of a healthy child (o two) | 38 weeks after embryo transfer |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Clavero, PhD | Investigator and laboratory specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de gestión clÃnica de ginecologÃa y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24798072 | Derived | Lopez-Regalado ML, Clavero A, Gonzalvo MC, Serrano M, Martinez L, Mozas J, Rodriguez-Serrano F, Fontes J, Castilla JA. Randomised clinical trial comparing elective single-embryo transfer followed by single-embryo cryotransfer versus double embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:192-8. doi: 10.1016/j.ejogrb.2014.04.009. Epub 2014 Apr 19. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elective Single Embryo Transfer | Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception |
| FG001 | Double Embryo Transfer | Transfer of two fresh embryos |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Elective Single Embryo Transfer | Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception |
| BG001 | Double Embryo Transfer | Transfer of two fresh embryos |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | percentage of pregnancy per transfer | Seven weeks after embryo transfer |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elective Single Embryo Transfer | Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| premature birth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Child birth before 37 gestational weeks |
Our study could have been complemented by improved embryo selection, using a time-lapse system.
Another limitation of our study is that after devitrification, blastocyst culture was not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ana Clavero | University Hospital Virgen de las Nieves | 0034958020482 | anaclaverogilabert@gmail.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Double embryo transfer | Procedure | After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Double Embryo Transfer |
Transfer of two fresh embryos |
|
|
| 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 | 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. | Posted | Number | percentage of multiple pregnancies | Seven weeks after embryo transfer |
|
|
|
| Other Pre-specified | Live Birth Delivery Rate | The delivery of a healthy child (o two) | 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. | Posted | Number | percentage of live birth | 38 weeks after embryo transfer |
|
|
|
| 0 |
| 84 |
| 3 |
| 84 |
| EG001 | Double Embryo Transfer | Transfer of two fresh embryos | 0 | 91 | 5 | 91 |
|
| Hiperstimulation Ovarian Syndrome | Reproductive system and breast disorders | Systematic Assessment | Syndrome of hiperactivation of ovarian function due to fertility treatments |
|
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