Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos

Study Overview
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Brief Summary
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This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos. The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.

Official Title
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Cumulative Pregnancy Rates and Direct Healthcare Cost Analysis of Two Different Strategies: Fresh Cleavage-stage Embryo Transfer (ET) on Day 3 With Vitrification of Supernumerary Embryos on Day 3 Versus Day 5

Conditions
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Subfertility

Intervention / Treatment
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* Procedure: Day of vitrification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment who are older than 18 and less than 38 years old who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels Exclusion Criteria: treatment with donor oocytes or donor embryos patients planned for Pre-implantation Genetic Diagnosis (PGD) Patients with BMI>30 patients with endometriosis grade III-IV

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day 3 vitrification<br>Day of vitrification of supernumerary embryos is day 3 | Procedure: Day of vitrification<br>* Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5<br>|
| Active Comparator: Day 5 vitrification<br>Day of vitrification of supernumerary embryos is day5 | Procedure: Day of vitrification<br>* Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative pregnancy rate | The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles) | Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost analysis | cost analysis of day 3 and day 5 vitrification strategy | Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year |