A controlled randomised study to compare the IUI biochemical pregnancy outcome between a routine swim-up and the Sep-D Kit semen preparation method

Autor: Gentis, Roxanne
Rok vydání: 2013
Předmět:
Druh dokumentu: Diplomová práce
Popis: Thesis (MScMedSc)--Stellenbosch University, 2013.
ENGLISH ABSTRACT: Male factor infertility is a general term that describes couples in which an inability to conceive is associated with a problem identified in the male partner. Intrauterine insemination (IUI) together with ovulation induction has been shown to be an effective treatment method for male factor infertility. Oocyte production by the ovaries is stimulated by the use of fertility drugs. A prepared sperm sample is then injected into the uterus through the vagina using an IUI catheter which brings the oocytes and spermatozoa into close proximity. Semen preparation is an integral part of an IUI cycle. In a developing country, a simple inexpensive semen preparation method for IUI procedures, not necessitating a lot of equipment, is essential. An example of such a method, the Sep-D Kit (Surelife Sep-D Kit, Surelife Media Technologies Pty Ltd, Singapore) has been proposed as a possible preparation method. In a pilot study performed by the principal investigator (Roxanne Gentis), comparing the Sep-D Kit and standard swim-up preparation methods, it was found that the Sep-D Kit compared very well with the swim-up method regarding most pre- and post-preparation semen parameters. The Sep-D Kit method, however, still needed further testing to see whether or not pregnancy rates resulting from the method are comparable with that resulting from the standard swim-up method, as this ultimately is the required result of an IUI. The primary aim of this study was to compare the Sep-D Kit method to the standard swim-up method with regards to biochemical pregnancy outcome, post-preparation sperm count, motility, total motile count (TMC), morphology, DNA compaction and fragmentation (CMA3 and TUNEL). The secondary aim was to evaluate which variables, male and female, affect biochemical pregnancy outcome. The study took place at Drs Aevitas Fertility Clinic, Vincent Pallotti Hospital, Pinelands. The study was a prospective analytical study and was conducted from December 2010 until October 2012. A total of 473 IUI cycles were evaluated. Results showed that the Sep-D Kit semen preparation method was non-inferior to the standard swim-up method with regards to biochemical pregnancy rates, post-preparation count and TMC. The swim-up method produced samples with a significantly higher post-preparation motility compared to the Sep-D Kit method, however both methods still managed to produce similar biochemical pregnancy rates (10.39% for the swim-up group versus 11.57% for Sep-D Kit group). For the total cohort of cycles analysed the only female parameter which significantly predicted biochemical pregnancy outcome in this study was age. Sperm motility (post-preparation) was the only male parameter that significantly affected biochemical pregnancy outcome. The Sep-D Kit method is more cost effective and also time saving compared to the swim-up method. There is also no need for expensive laboratory equipment or a trained embryologist using the Sep-D Kit preparation method. The Sep-D Kit may therefore be used with confidence as a standard semen preparation method, and may be implemented in developing countries for use in routine IUI procedures.
AFRIKAANSE OPSOMMING: Manlike faktor infertiliteit is 'n algemene term wat gebruik word om paartjies te beskryf wat 'n onvermoë toon om swanger te raak as gevolg van 'n probleem wat geassosieer word met die man. Die kombinasie van intra-uteriene inseminasie (IUI) en ovulasie induksie kan doeltreffend gebruik word om manlike faktor infertiliteit te behandel. Vrugbaarheidsmiddels word gebruik om oösietproduksie in die die eierstokke te stimuleer en 'n voorbereide spermmonster word dan transvaginaal in die baarmoeder ingespuit om sodoende die spermatozoa en oösiete na-aan mekaar te bring. Semenvoorbereiding is 'n integrale deel van 'n IUI siklus en in 'n ontwikkelende land is 'n eenvoudige, goedkoop semenvoorbereidingsmetode – wat die gebruik van duur toerusting uitsluit – noodsaaklik. Die Sep-D Kit metode (Surelife Sep-D Kit, Surelife Media Technologies Pty Ltd, Singapore) is 'n voorbeeld van so 'n voorbereidingsmetode. 'n Loodsstudie, uitgevoer deur die hoofnavorser, (Roxanne Gentis), het gewys dat die Sep-D Kit en standaard opswem voorbereidingmetodes goed vergelyk ten opsigte van meeste semenparameters voor- en na voorbereiding. Dit is egter ook noodsaaklikheid vir verdere navorsing om vas te stel of swangerskapuitkoms na die gebruik van die twee semenvoorbereidingsmetodess vergelykbaar is, aangesien dit die uiteindelike, verlangde uitkoms van 'n IUI is. Die primêre doel van hierdie studie was om die Sep-D Kit metode te vergelyk met die standaard opswemmetode met betrekking tot biochemiese swangerskapuitkoms asook spermtelling, motiliteit, totale motiele spermtelling (TMS), morfologie, DNA kompaksie en fragmentering (CMA3 en TUNEL) na spermvoorbereiding. Die sekondêre doel was om te evalueer watter veranderlikes, manlik en vroulik, die bichemiese swangerskapuitkoms beïnvloed. Die studie is uitgevoer by die Drs Aevitas Fertiliteitskliniek, Vincent Pallotti Hospitaal, Pinelands. Die studie was prospektief analities en het gestrek vanaf Desember 2010 tot en met Oktober 2012. 'n Totaal van 473 IUI siklusse is evalueer en ontleed. Die resultate van die studie het getoon dat die Sep-D Kit semenvoorbereidingsmetode nie ondergeskik aan die opswemmetode was ten opsigte van biochemiese swangerskap, spermtelling en TMS na semenvoorbereiding nie, Spermmotiliteit was betekenisvol hoër vir die opswemmetode vergelykend met die Sep-D Kit, maar ten spite van die verskil was die biochemiese swangerskapsyfers in die twee groepe nie verskillend nie (10.39% in die opswem groep en 11.57% in Sep-D Kit groep). In die totale kohort siklusse wat ontleed is was dit net die ouderdom van die vrou wat 'n betekenisvolle effek op biochemiese swangerskapuitkoms gehad het. Die enigste manlike faktor wat 'n betekenisvolle effek op biochemiese swangerskapuitkoms gehad het was die motiliteit na semenvoorbereiding. Die Sep-D Kit metode is meer koste-effektief en tydbesparend as die standard opswemmetode. Die uitvoer van die Sep-D Kit metode vereis ook ook geen duur apparaat of 'n opgeleide embrioloog nie. Die Sep-D Kit metode kan dus met vertroue gebruik word as 'n standaard semenvoorbereidingsmetode en kan in ontwikkelende lande vir gebruik tydens roetine IUI prosedures geïmplementeer word.
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