Condition category
Urological and Genital Diseases
Date applied
10/12/2013
Date assigned
20/01/2014
Last edited
28/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonio Capalbo

ORCID ID

Contact details

Via G. De Notaris 2/b
Rome
00197
Italy
+39 (0)63269791
capalbo@generaroma.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GENERA0042013

Study information

Scientific title

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

Acronym

Study hypothesis

A non-selection prospective randomised controlled trial to define the real influence of morphology and developmental rate of euploid blastocysts on ongoing implantation rate. Outcomes of morphologically different blastocysts transferred in intracytoplasmic sperm injection (ICSI) cycles of women undergoing preimplantation genetic screening (PGS) will be compared. Morphology will be evaluated accordingly to Gardner and Schoolcraft (1994) and blastocysts will be grouped into four classes (poor, average, good and excellent morphology). Also, developmental rate will be considered and blastocysts will be grouped into two classes (faster growing if reaching a stage compatible with biopsy on day 5 of embryo development, slower growing if reaching the same stage on day 6 or 7). According to the study hypothesis, conventional parameters of blastocyst evaluation do not relate with implantation during euploid frozen blastocyst transfer cycles.

Ethics approval

Local Medical Ethics Committee (Clinica Valle Giulia Ethics Committee), 01/12/2013, GENERA0042013_ethical approval

Study design

Non-selection randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infertility in females undergoing PGS cycles

Intervention

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 vitro fertilization performed by intracytoplasmic sperm injection (ICSI)
4. In vitro culture performed with sequential media in 6% CO2 and 5% O2 atmosphere
5. Trophectoderm biopsy will be performed when the embryo will reach the expanded blastocyst stage. Blastocysts will be cryopreserved thereafter by vitrification, in order to perform the transfer in a thawing cycle
6. Blastocysts will be graded according to Gardner and Schoolcraft (1994)
7. Diagnosis will be performed through quantitative polymerase chain reaction (qPCR) by a referral center
8. In case more than one euploid blastocyst is found in the same cohort from a patient, the embryo to be thawed and transferred will be randomized on the day of transfer by an independent operator. If a patient produces a single euploid blastocyst, it will be directly transferred and included in the study.
9. Luteal support by Progesterone 200 mg vaginally three times a day from oocyte retrieval plus one day

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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 β-hCG positive test without a proper clinical pregnancy divided by the total number of transfers resulting in a β-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.

Overall trial start date

01/12/2013

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300 frozen single blastocyst transfer cycles

Participant 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

Recruitment start date

01/12/2013

Recruitment end date

01/12/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Via G. De Notaris 2/b
Rome
00197
Italy

Sponsor information

Organisation

Genera Centre for Reproductive Medicine (Italy)

Sponsor details

Via G. De Notaris 2/b
Rome
00197
Italy
+39 (0)63269791
capalbo@generaroma.it

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

G.EN.E.R.A. Centre for Reproductive Medicine (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes