Plain English Summary
Background and study aims
In vitro fertilisation (IVF) techniques help people with fertility problems to have a baby. ICSI (intracytoplasmic sperm injection) is an IVF technique in which a single sperm is injected into the centre of an egg. The resulting embryo can be transferred into the woman’s womb when they are at cleavage stage (day 2 to 3) or at blastocyst stage (day 5 to 6). The aim of this study is to compare blastocyst stage transfer and cleavage stage transfer in women undergoing IVF/ICSI.
Who can participate?
Women aged 37 to 42 undergoing IVF/ICSI
What does the study involve?
Participants are randomly allocated to undergo either blastocyst stage transfer or cleavage stage transfer. Live birth rate, delivery rate, multiple pregnancy rate, health of the child, and time to pregnancy are compared in the two groups.
What are the possible benefits and risks of participating?
These strategies are expected to result in comparable delivery rates, but the time required to achieve pregnancy is expected to be shorter in the blastocyst transfer group.
Where is the study run from?
GENERA Centre for Reproductive Medicine (Italy)
When is the study starting and how long is it expected to run for?
November 2011 to December 2012
Who is funding the study?
GENERA Centre for Reproductive Medicine (Italy)
Who is the main contact?
Dr Laura Rienzi
rienzi@generaroma.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Laura Francesca Rienzi
ORCID ID
Contact details
Via De Notaris 2B
Rome
00197
Italy
+39 (0)33 56 153 691
rienzi@generaroma.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
032012
Study information
Scientific title
Blastocyst stage vs cleavage stage transfer in women with increased maternal age: a prospective randomised controlled trial
Acronym
Study hypothesis
A prospective randomised controlled trial to compare two strategies: blastocyst stage transfer and cleavage stage transfer in Intracytoplasmic Sperm Injection (ICSI) cycles of women aged between 37 and 42 years old. These strategies are expected to have comparable cumulative outcomes for delivery rates. Blastocyst transfer is expected to have favorable outcomes per transfer. The hypothesis is the non-inferiority of cleavage stage strategy when the delivery rate is calculated cumulatively. However, the time to achieve the pregnancy is expected to be shorter in the blastocyst transfer group.
Ethics approval
Local Medical Ethics Committee [Clinica Valle Giulia Ethics Committee], 20/09/2011
Study design
Prospective randomized double blinded study
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 to request a patient information sheet
Condition
Infertility in females aged between 36 and 42 years
Intervention
Patients will be randomised on the day of ovum pick up by a independent operator to:
1. Blastocyst transfer:
1.1. Ovarian stimulation by agonist or antagonist protocol
1.2. Ovum pick up performed 36 hours after human chorionic gonadotropin (HCG) administration
1.3. In vitro fertilization performed by intracytoplasmic sperm injection (ICSI)
1.4. In vitro culture performed with sequential media in 6% CO2 and 5% O2 atmosphere
1.5. Embryo transfer on day 5 two best quality blastocyst. Remaining blastocyst preserved by vitrification procedure
1.6. Luteal support by Progesterone 200 mg vaginally three times a day from oocyte retrieval plus one day
2. Cleavage stage transfer:
2.1. Ovarian stimulation by agonist or antagonist protocol
2.2. Ovum pick up performed 36 hours after Human chorionic gonadotropin (HCG) administration
2.3. In vitro fertilization performed by intra-cytoplasmic sperm injection (ICSI)
2.4. In vitro culture performed with sequential media in 6% CO2 and 5% O2 atmosphere
2.5. Embryo transfer on day 3 two best quality embryos. Remaining embryos preserved by vitrification procedure
2.6. Luteal support by Progesterone 200mg vaginally three times a day from oocyte retrieval plus one day
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Cumulative live birth rate after blastocyt or cleavage stage strategy including pregnancies from
fresh + cryoembryos transferred within 6 months after the end of the treatment
Secondary outcome measures
1. Delivery rate per transfer
2. Multiple pregnancy rate
3. Pregnancy/childbirth: all women will be contacted to ask information on the delivery and on the health of the child: week of delivery, weight of the child, major and minor malformation
4. Time to pregnancy: the time to obtain the pregnancy from ovum pick up
Overall trial start date
01/11/2011
Overall trial end date
01/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients aged between 37 and 42 years undergoing an IVF/ICSI attempt at the GENERA centre for Reproductive Medicine in Rome
2. History of less than 3 failed IVF/ICSI cycles
3. ≥6 MII retrieved
4. Signed consent form
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Participant exclusion criteria
1. Woman younger than 37 years and older than 42 years
2. Positive serology for Hepatitis B, C or HIV
3. Diminished ovarian reserve: early follicular serum FSH > 10 IU/l and/or poor response during earlier COH/IVF or COH/ICSI (less than 6 follicles)
4. Persisting ovarian cysts > 30 mm diameter
5. Severe male factor infertility (Azoospermia)
Recruitment start date
01/11/2011
Recruitment end date
01/12/2012
Locations
Countries of recruitment
Italy
Trial participating centre
GENERA Centre for Reproductive Medicine
Rome
00197
Italy
Sponsor information
Organisation
GENERA Centre for Reproductive Medicine (Italy)
Sponsor details
via De Notaris
2B
Rome
00197
Italy
+39 (0)33 56 153 691
rienzi@generaroma.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
GENERA 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
Basic results (scientific)
Publication list