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

Influence of morphological grade and developmental rate on euploid blastocysts implantation potential: a non-selection prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81216689
Enrollment
300
Registered
2014-01-20
Start date
2013-12-01
Completion date
Unknown
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The study would be structured as follows: 1. Ovarian stimulation by agonist or antagonist protocol 2. Ovum pick up performed 36 hours after human chorionic gonadotropin (HCG) administration 3. In vi

Sponsors

Genera Centre for Reproductive Medicine (Italy)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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. 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. 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.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026