Trial evaluating the influence of morphology and developmental rate on euploid blastocysts ongoing implantation rate

Not Applicable

Completed

Conditions: Infertility in females undergoing PGS cycles
Urological and Genital Diseases
Female infertility

Registration Number: ISRCTN81216689

Lead Sponsor: Genera Centre for Reproductive Medicine (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 300

Inclusion Criteria

1. All consecutive patients enrolled for blastocyst stage PGS cycles
2. Signed consent form

Exclusion Criteria

1. Positive serology for hepatitis B or C or HIV
2. Persisting ovarian cysts > 30 mm diameter
3. Patient is a carrier of monogenic diseases or chromosomal abnormalities
4. Known American Society for Reproductive Medicine (ASRM) Grade III or IV endometriosis
5. Maternal disease that is not clinically stable and known to impact the ability to become pregnant or carry a pregnancy to term
5.1. Lupus
5.2. Chronic liver or kidney disease
5.3. Body mass index (BMI) greater than 30
5.4. Uncontrolled hypertension
5.5. Anti-phospholipid antibody
5.6. Thrombophilia
5.7. Insulin-dependent diabetes

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ongoing implantation rate. It will be expressed as the number of blastocyst implanted (after 12 weeks) from the day of embryo transfer divided by the total number of blastocysts transferred. It will be updated up to 12 weeks from the last blastocyst transfer performed before the 01/12/2014.

Secondary Outcome Measures

Name	Time	Method
1. Survival rate. It will be expressed as the number of surviving blastocysts after thawing divided by the total number of blastocysts thawed up to 01/12/2014.<br>2. Re-expansion rate within 3 hours post warming. It will be expressed as the number of blastocysts re-expanding within no more than 3 hours after thawing divided by the total number of blastocysts surviving to the warming procedure up to 01/12/2014.<br>3. Biochemical rate. It will be expressed as the number of transfers resulting in a ß-hCG positive test without a proper clinical pregnancy divided by the total number of transfers resulting in a ß-hCG positive test. It will be updated up to 2 weeks from the last blastocyst transfer performed before 01/12/2014.<br>4. Abortion rate. It will be expressed as the number of miscarriages divided by the total number of clinical pregnancies. It will be updated up to 12 weeks from the last blastocyst transfer performed before 01/12/2014.