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L-AGE studie


- candidate number4114
- NTR NumberNTR1457
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2008
- Secondary IDs04-01 
- Public TitleL-AGE studie
- Scientific TitleThe effect on embryo-quality of rLH-addition to rFSH for controlled ovarian hyperstimulation in women with poor ovarian reserve
- ACRONYML-AGE
- hypothesisControlled ovarian hyperstimulation with gonadotrophins containing a 2:1 FSH-LH ratio, leads to more competent embryos and pregnancies compared to rFSH alone, in women between 35 and 43 years of age and women with IOF undergoing a long GnRH agonist downregulated IVF or ICSI protocol.
- Healt Condition(s) or Problem(s) studiedPregnancy, In vitro fertilization (IVF), Ovarian stimulation, Luteinizing hormone (LH)
- Inclusion criteria1. Patients between 35 and 43 years of age
2. Patients with IOF, <35 years
3. Valid indication for IVF or ICSI
4. Undergoing IVF/ICSI first oocyte retrieval
- Exclusion criteriaEndocrinopathological disease as: Cushing’s syndrome, adrenal hyperplasia, hyperprolactinaemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I, PCOS If not willing or able to sign the informed consent form
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2008
- planned closingdate1-dec-2009
- Target number of participants220
- Interventions1. 300 rFSH sc daily alone or
2. 2:1 ratio rFSH : rLH i.e. 300 IU/L rFSH and 150 IU/L rLH sc
- Primary outcomePercentage of top-quality embryos
- Secondary outcome- Number of follicles > 14 mm on hCG day
- Number of retrieved oocytes
- Number of metaphase II oocytes
- Pronuclear morphology
- Total number of embryos
- Presence of early cleavage
- Cleavage stage morphology
- Number of embryos suitable for transfer
- Biochemical, clinical, ongoing pregnancies
- Live-birth rate
- Timepoints3 days after oocyte retrival
- Trial web sitehttp://www.studies-obsgyn.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.M. Musters
- CONTACT for SCIENTIFIC QUERIES A.M. Musters
- Sponsor/Initiator Academic Medical Center (AMC), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
MerckSerono
- PublicationsN/A
- Brief summaryRandomized, clinical study in 220 women from 35 years of age and women with IOF undergoing IVF/ICSI. We will study the effects on embryo quality -in terms of morphological quality- of rFSH alone compared to a 2:1 ratio rFSH and rLH, with an initial starting dose of 300 IU rFSH. Embryological morphology scoring criteria will be assesed, i.e. pronuclear morphology, the presence of early cleavage, and cleavage-stage morphology until the time of transfer.
- Main changes (audit trail)
- RECORD24-sep-2008 - 1-okt-2008


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