The objective of this study was to compare the efficacy and safety of a recombinant follicle stimulating hormone (FSH) preparation (Org 32489, Puregon) with a urinary FSH preparation (Metrodin) in infertile women undergoing in-vitro fertilization (IVF and embryo transfer and who were pituitary-suppressed with triptorelin. In an assessor-blind, group-comparative, multicentre study, 60 women were randomized to Org 32489 and 39 to urinary FSH. An evaluation of the main parameter, the mean total number of oocytes recovered, indicated a similar efficacy for the two preparations: 9.7 with Org 32489 versus 8.9 with urinary FSH. In addition, there were no significant between-group differences with respect to other efficacy variables such as the total dose used, the duration of the treatment, the number of follicles > or = 17 mm in diameter and embryo quality. The ongoing pregnancy rates per attempt (30.2 versus 17.4%) and per transfer (34.0 versus 18.8%) were higher with Org 32489, but this difference was not statistically significant. No clinically relevant differences between Org 32489 and urinary FSH were seen with respect to safety variables. Serum antibodies were not detected in any of the subjects. It is concluded that Org 32489 compares favourably with urinary FSH in the treatment of infertile pituitary-suppressed women undergoing IVF and embryo transfer.
Pronuclear morphology has been reported as a good tool for studying embryo development and euploidy. Comparing two groups of women with different aneuploidy risk, women more than 38 years old (n = 28) known to be at high risk of aneuploidy, and women under 30 years old (n = 35), this study investigated whether pronuclear morphology could be used routinely as an alternative to preimplantation genetic screening (PGS) in countries where PGS is prohibited. Pronuclear morphology was evaluated for 301 zygotes and related to embryo quality and pregnancy outcome. For the older women, an increased frequency of zygotes with abnormal polar body and pronuclei alignment was observed, i.e. type gamma, with 93% aneuploidy risk (26.0 versus 15.1% P < 0.05) and fewer zygotes with a good development prognosis (36.4 versus 47.8%; P < 0.05). A1alpha configuration was associated with good implantation rate and was not related to day 2 embryo quality. This configuration was less frequent in the group of women more than 38 years old and among non-pregnant women under 30 years, compared with pregnant women under 30 years old. Pronuclear morphology seemed linked to age, but not associated with embryo quality. A larger study allowing correlation analysis is necessary to confirm the value of these criteria and the link to a woman's age.
The results of histological examination of the endometrium are normal in most patients with unexplained sterility. Cathepsin D is a ubiquitous lysosomal protease regulated by progesterone in the endometrium. Assays of concentrations of cathepsin D might be useful in determining the functional responses of the endometrium to progesterone. To examine this possibility, we quantified immunostaining of endometrial cathepsin D using an image analysis system in women with regular menstrual cycles. An endometrial sample was obtained during the proliferative and luteal phases from 17 women with ovulatory menstrual cycles and at the beginning and during the last 14 days of a cycle from 15 women having anovulatory menstrual cycles. In endometrial glands of ovulatory women, cathepsin D protein immunostaining increased during the cycle and was significantly higher during the luteal than during the proliferative phase [51 +/- 38.1 arbitrary units (AU) versus 118.2 +/- 58.9 AU; P < 0.01]. This increase was also observed in stromal cells, although to a lesser extent (28.6 +/- 26.9 versus 41.5 +/- 43.1 AU; P = NS). In the endometrium of women with anovulatory menstrual cycles, cathepsin D staining was high both for the proliferative and the luteal biopsies in glands (respectively 95 +/- 43 and 104 +/- 51.3 AU) and stromal cells (respectively 61.8 +/- 33.8 and 75 +/- 32.6 AU). In women with ovulatory cycles, cathepsin D staining was localized in the apical part of glandular cells during the proliferative phase and diffused throughout the cytoplasm during the luteal phase. In contrast, in women with anovulatory cycles, cellular localization of cathepsin D remained apical in glands, regardless of the day of biopsy. In conclusion, this study shows that the cytoplasmic localization of cathepsin D might be a qualitative biological indicator of endometrial gland responses to progesterone. This could be a useful tool for evaluating cell function, which is poorly tested by histology alone.
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