Skip to content

Trial comparing blastocyst transfer with cleavage stage transfer in women with increased maternal age

Blastocyst stage vs cleavage stage transfer in women with increased maternal age: a prospective randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48090543
Enrollment
400
Registered
2011-12-28
Start date
2011-11-01
Completion date
Unknown
Last updated
2017-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility in females aged between 36 and 42 years Urological and Genital Diseases Female infertility

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

Sponsors

GENERA Centre for Reproductive Medicine (Italy)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026