Condition category
Urological and Genital Diseases
Date applied
27/10/2011
Date assigned
28/12/2011
Last edited
06/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 4

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laura Francesca Rienzi

ORCID ID

Contact details

Via De Notaris 2B
Rome
00197
Italy
+39 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. Our 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 September 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 below 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 will be recorded
4. Time to pregnancy: the time to obtain the pregnancy from ovum pick up will be calculated

Overall trial start date

01/11/2011

Overall trial end date

01/12/2012

Reason abandoned

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

Via De Notaris 2B
Rome
00197
Italy

Sponsor information

Organisation

GENERA Centre for Reproductive Medicine (Italy)

Sponsor details

via De Notaris
2B
Rome
00197
Italy
+39 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes