| - candidate number | 2418 |
| - NTR Number | NTR876 |
| - ISRCTN | ISRCTN24724622 |
| - Date ISRCTN created | 8-feb-2007 |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 22-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | Follikel diameter studie |
| - Scientific Title | Timing of hCG administration according to predetermined criteria of follicular size. |
| - ACRONYM | |
| - hypothesis | To assess whether delayed administration of hCG for controlled ovarian hyperstimulation for in In Vitro Fertilization and embryo transfer leads to an increased advanced stage of endometrium, and prolonged exposure to high levels of Estradiol which may result in a lower pregnancy rate. |
| - Healt Condition(s) or Problem(s) studied | Timing Humane Chorion Gonadotropine (HCG), Follicle size, In vitro fertilization (IVF) |
| - Inclusion criteria | 1. Age between 18 and 42 and 11 months; 2. Valid indication for IVF or ICSI; 3. Undergoing their first or second IVF/ICSI attempt; 4. Normal FSH levels (< 15); 5. Antral follicle count > 5 for women between 40 and 43. |
| - Exclusion criteria | 1. Endocrinopathological disease as: PCOS, cushing syndrome, adrenal hyperplasia, hyperprolactinaemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I; 2. Premature ovarian failure defined as a FSH level on cycle-day 3 of ¡Ý 15 IU at the age of 40; 3. Low responders defined as follicle growth of less than 3 follicles during controlled ovarian hyperstimulation (including the dominant follicle). |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-apr-2006 |
| - planned closingdate | 1-apr-2008 |
| - Target number of participants | 400 |
| - Interventions | hCG administration for follicular maturation when the dominant follicle measures 18 mm compared to hCG administration for follicular maturation when the dominant follicle measures 22 mm |
| - Primary outcome | Ongoing pregnancy rate, defined as a positive foetal heartbeat by ultrasound at 10 weeks after oocyte retrieval. |
| - Secondary outcome | Endometrium thickness, 3-layer aspect Total days of controlled hyper stimulation Total amount of rFSH used Total number of retrieved oocytes Number of Score I oocytes (IVF only) Number of metaphase II oocytes (ICSI only) Fertilization rate Number and quality of embryos Pronuclear morphology Presence of early cleavage Daily morphological quality of embryos until transfer Number of embryos suited for cryo-preservation OHSS/ discontinuation due a high risk of OHSS Biochemical and clinical pregnancy rates, defined as a increase in serum HCG or a positive pregnancy test and positive heartbeat by ultrasound at 7 weeks after oocyte retrieval, respectively. |
| - Timepoints | |
| - Trial web site | http://www.studies-obsgyn.nl |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | MD. M.H. Mochtar |
| - CONTACT for SCIENTIFIC QUERIES | MD. PhD. Fulco Veen, van der |
| - Sponsor/Initiator | Academic Medical Center (AMC), Center For Reproductive Medicine |
| - Funding (Source(s) of Monetary or Material Support) | Organon |
| - Publications | N/A |
| - Brief summary | After the introduction of GnRH agonists for controlled ovarian hyperstimulation (COH) in In Vitro Fertilisation and embryo transfer (IVF-ET), the duration of follicular growth was no longer restricted by the anticipation of a premature LH surge (Porter el al 1984). It became possible to schedule final oocyte maturation and subsequent oocyte retrieval, not according to follicle size, but according to the convenience of patients and doctors. True evidence, however, whether the moment of inducing final oocyte maturation in the follicular phase is crucial or not in order to achieve good pregnancy rates, was not sought thoroughly. Arbitrarily criteria have been used for administering hCG. Objective Our objective is to explore whether timing of hCG according to predetermined criteria of follicular size leads to higher ongoing pregnancy rates in GnRH agonists down-regulated COH IVF-ET cycles. Study design A randomised clinical trial. Population Women undergoing IVF or ICSI, aged between 18 and 43 years and who have an indication for IVF or ICSI treatment according to the Dutch NVOG guidelines are eligible for the trial. The patients may only participate for one treatment cycle (a first or second cycle) Stratification will be performed according to IVF or ICSI treatment and first or second cycles. Intervention and follow-up Standard GNRH agonist long luteal protocol combined with recombinant FSH daily of 50, 150, 225 IU subcutaneously, and (1) hCG 10.000 IU administration, subcutaneously, as soon as the leading follicle measures 18 mm3 (± 1mm3) for final oocyte maturation, or (2) hCG administration as soon as the leading follicle measures 22 mm3 (± 1mm3). Oocyte retrieval will be performed 36 hours after hCG administration. Embryo-transfer is started 72 hours after oocyte retrieval. Luteal phase support is started at the evening after oocyte retrieval. Follow-up is one completed IVF/ICSI treatment cycle or in case of pregnancy: untill ongoing pregnancy |
| - Main changes (audit trail) | |
| - RECORD | 22-jan-2007 - 9-feb-2007 |
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