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22 May 2012
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Trial comparing blastocyst transfer with cleavage stage transfer in women with increased maternal age
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| ISRCTN | ISRCTN48090543 |
| ClinicalTrials.gov identifier | |
| Public title |
Trial comparing blastocyst transfer with cleavage stage transfer in women with increased maternal age
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| Scientific title | Blastocyst stage vs cleavage stage transfer in women with increased maternal age: a prospective randomised controlled trial |
| Acronym | N/A |
| Serial number at source | 032012 |
| 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. |
| Lay summary | Lay summary under review |
| Ethics approval | Local Medical Ethics Committee [Clinica Valle Giulia Ethics Committee], 20 September 2011 |
| Study design | Prospective randomized double blinded study |
| Countries of recruitment | Italy |
| Disease/condition/study domain | Infertility in females aged between 36 and 42 years |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/11/2011 |
| Anticipated end date | 01/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 400 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | GENERA Centre for Reproductive Medicine (Italy) |
| Trial website | |
| Publications | |
| Contact name | Dr Laura Francesca Rienzi |
| Address | Via De Notaris 2B |
| City/town | Rome |
| Zip/Postcode | 00197 |
| Country | Italy |
| Tel | +39 33 56 153 691 |
| rienzi@generaroma.it | |
| Sponsor | GENERA Centre for Reproductive Medicine (Italy) |
| Address | via De Notaris, 2B |
| City/town | Rome |
| Zip/Postcode | 00197 |
| Country | Italy |
| Tel | +39 33 56 153 691 |
| rienzi@generaroma.it | |
| Date applied | 27/10/2011 |
| Last edited | 28/12/2011 |
| Date ISRCTN assigned | 28/12/2011 |
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