eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer

Conditions
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Infertility, Pregnancy, Multiple

Intervention / Treatment
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* Procedure: Elective single embryo transfer
* Procedure: Double embryo transfer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elective single embryo transfer<br>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 | Procedure: Elective single embryo transfer<br>* 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.<br>|
| Active Comparator: Double embryo transfer<br>After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos | Procedure: Double embryo transfer<br>* After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |