|- candidate number||7702|
|- NTR Number||NTR2194|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-jan-2010|
|- Secondary IDs||26347.0000.09 CCMO|
|- Public Title||Monofollicular IVF punctates.|
|- Scientific Title||A novel simple method to obtain monofollicular punctates and the corresponding oocytes during oocyte pick ups for IVF or IVF/ICSI.|
|- hypothesis||With the use of the special rd needle, the yield of oocytes will not be diminished when compared with the use of the routine needle. Moreover the percentage of top quality oocytes wil be the same with the use of both needles.|
|- Healt Condition(s) or Problem(s) studied||Infertility, IVF|
|- Inclusion criteria||1. Number of follicles in each ovary between 2 and 10 on the day of oocyte pick up;|
2. Oocyte pick up not during the weekend;
3. Oocyte pick up in routine setting (i.e. not under general anaesthesia).
|- Exclusion criteria||None.|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2010|
|- planned closingdate||1-jun-2010|
|- Target number of participants||60|
|- Interventions||All couples who will be starting an IVF or ICSI treatment in the ErasmusMC are being invited for an information evening (in which the entire treatment as well as the laboratory procedures will be explained). Within weeks after this evening an intake with these couples willl take place. Thereafter the iVF treatment will actually start.
During the information evening, the researcher will present a couple of slides regarding the study. Moreover, couples will receive the patient information form. During intake, the fertilitity doctor will ask the couple to participate. Couples can get additional information if needed at that moment. This is the moment to sign the informed consent.
If on the day of ovum pick up a patient turns out to be elegible, and if she has signed the informed consent, randomisation can take place. The randomisation dictates which ovary will be punctured monofillicular and which pooled. The right ovary will allways be punctured first. All ovum pick ups will be performed by the same doctor (the researcher).
|- Primary outcome||The yield of oocytes per number of follicles> 10mm, monofollicular versus pooled.
|- Secondary outcome||1. % fertilisation, monofollicular versus pooled;|
2. % top quality embryo’s monofollicular versus pooled;
3. Mean diameter of the 1st monofollicular punctured follicle related to the obtained amount of follicular fluid;
4. Painscore during oocyte pick up of both ovaries (ie monofollicular vs pooled).
|- Timepoints||1. Day of oocyte pick up (yield, painscores and obtained volume in relation to measured diameter);|
2. 1 day post oocyte pick up (% fertilization);
3. 3 days post oocyte pick up (% top quality embryo's).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||dr. N.G.M. Beckers|
|- CONTACT for SCIENTIFIC QUERIES||dr. N.G.M. Beckers|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Obstetrics and Gynecology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Obstetrics and Gynaecology|
|- Brief summary||In routine IVF treatments, pre-ovulatory follicles are punctuated under different circumstances. In the early days of IVF, the laparoscopic (Steptoe and Edwards 1970) and the transvescical (Robertson, Picker et al. 1986) method was used, while today all oocyte retrievals are being done vaginally (Kemeter and Feichtinger 1986). Some clinics routinely flush the follicles (Bagtharia and Haloob 2005) and others don’t. In most cases the obtained punctate will be pooled, ie fluid and the oocytes from different follicles will be collected in one larger bottle or tube, as the follicles will be punctuated one after another without withdrawing the needle again and again. This method is obviously simple and fast. However, today, an increasing interest exists in different parameters regarding the micro environment of the oocyte in relation to oocyte and embryo quality, implantation and pregnancy outcome (Boxmeer, Brouns et al. 2008), (Rosen, Shen et al. 2007). Therefore, some authors have published data after retrieving mono-follicular punctuates (Boxmeer, Brouns et al. 2008).
Different methods exist to obtain a mono-follicular punctate. A single follicle can be punctured and the fluid from this single follicle can be collected in a separate bottle or tube. The bottle will be replaced (without withdrawing the needle from the ovary) and the next follicle will be punctured. The disadvantage of this method is that a relatively large amount of the follicular fluid of the first follicle will not be collected in the separate first sample but will stay behind in the tubing and the needle of the collecting system. This fluid will be collected during puncturing the next follicle. Therefore concentrations of different contents of the fluid of a single follicle can only be assessed from the first sample, as the consecutive samples will be mixed. Moreover, as a relatively large amount of fluid remains in the tubing and needle, the chance that the corresponding oocyte is present in the separate first sample is relatively low. To overcome these problems it is also possible to withdraw the needle from the ovary and change bottles after puncturing every single follicle. This will obviously increase duration of the procedure, increase pain and discomfort for the patients and probably cause more tissue damage in the ovaries (El-Shawarby, Margara et al. 2004).
In order to be able to collect mono follicular samples together with the corresponding oocyte effectively a new oocyte pick up needle was designed and manufactured (Gynotec, Malden, The Netherlands). The aim of this study examine the effectivity and safety of the use of this new needle.
|- Main changes (audit trail)|
|- RECORD||29-jan-2010 - 14-feb-2010|