Trial comparing blastocyst transfer with cleavage stage transfer in women with increased maternal age
| ISRCTN | ISRCTN48090543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48090543 |
| Secondary identifying numbers | 032012 |
- Submission date
- 27/10/2011
- Registration date
- 28/12/2011
- Last edited
- 14/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Via De Notaris 2B
Rome
00197
Italy
| Phone | +39 (0)33 56 153 691 |
|---|---|
| rienzi@generaroma.it |
Study information
| Study design | Prospective randomized double blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Blastocyst stage vs cleavage stage transfer in women with increased maternal age: a prospective randomised controlled trial |
| Study objectives | 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(s) | Local Medical Ethics Committee [Clinica Valle Giulia Ethics Committee], 20/09/2011 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2011 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 400 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 01/12/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
00197
Italy
Sponsor information
Hospital/treatment centre
via De Notaris, 2B
Rome
00197
Italy
| Phone | +39 (0)33 56 153 691 |
|---|---|
| rienzi@generaroma.it | |
"ROR" |
https://ror.org/05aq4y378 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/11/2017: Plain English summary added.
