Endometrial biopsies showing inadequate development were observed after ovarian stimulation with the GnRH agonist Buserelin and HMG for IVF or GIFT when luteal supplementation was omitted. Ninety-one patients were randomly allocated to two luteal supplementation regimens: in 41 women HCG and in 50 women progesterone and oestradiol valerate. The pregnancy patients treated with a combination of the GnRH agonist and HMG a delay of implantation of 1.3 days was observed compared to pregnancies after clomiphene citrate-HMG stimulation. This delay was not due to slower preimplantation embryo development after GnRH agonist-HMG treatment. Temporarily defective function of the corpus luteum was evidenced by measuring serum progesterone, 17 beta-oestradiol and 17-hydroxyprogesterone in the patients receiving progesterone and oestradiol valerate. This inadequate corpus luteum function could be related to the prolonged blockage of pituitary gonadotrophic function after arrest of the GnRH agonist.
In order to evaluate the safety of the intracytoplasmic sperm injection (ICSI) procedure, a prospective follow-up study of 423 children born after ICSI was carried out. The aim of this study was to compile data on karyotypes, congenital malformations, growth parameters and developmental milestones. Before starting the infertility treatment, couples were asked to participate in a follow-up study including genetic counselling and prenatal diagnosis. The follow-up study of the child was based on a visit to the paediatrician-geneticist at birth or at 2 months of age, at 1 year and at 2 years of age when a physical examination for major and minor malformations and a psychomotoric evaluation were done. Between April 1991 and September 1994, 320 pregnancies obtained after ICSI led to the birth of 423 children (222 singletons, 186 twins and 15 triplets). Prenatal diagnosis determined a total of 293 karyotypes, one of which was abnormal (0.3%), and four were benign familial structural aberrations, all inherited from the paternal side. A total of 14 (3.3%) major malformations were observed, defined as those causing functional impairment or requiring surgical correlation. Neurological or developmental problems at the age of 2 months were found in 14 children, four of whom were multiples. Compared to most registers of children born after assisted reproduction and to registers of malformations in the general population, the figure of 3.3% major malformations is within the expected range. Before drawing any firm conclusion, further careful evaluations of the available data are necessary.
A prospective follow-up study of 877 children born after ICSI was carried out. The aim of this study was to compile data on karyotypes, congenital malformations, growth parameters and developmental milestones so as to evaluate the safety of this new technique. The follow-up study included agreement to genetic counselling and prenatal diagnosis and was based on a physical examination at the Centre for Medical Genetics (Dutch-speaking Brussels Free University, Brussels, Belgium) at 2 months, 1 year and 2 years, when major and minor malformations and a psychomotor evolution were recorded. Between April 1991 and July 1995, 904 pregnancies obtained after intracytoplasmic sperm injection (ICSI) led to the birth of 877 children (465 singletons, 379 twins and 33 triplets). Prenatal diagnosis determined a total of 486 karyotypes, of which six were abnormal (1.2%) and six (1.2%) were familial structural aberrations, all transmitted from the father. This slight increase in de-novo chromosomal aberrations and the higher frequency of transmitted chromosomal aberrations are probably linked directly to the characteristics of the infertile men treated rather than to the ICSI procedure itself. In all, 23 (2.6%) major malformations were observed in the children born, defined as those causing functional impairment or requiring surgical correction. No particular malformation was disproportionately frequent. Compared with most registers of children born after assisted reproduction and with registers of malformation in the general population, the figure of 2.6% was within the expected range. These observations should be further completed by others and by collaborative efforts. In the meantime, patiens should be counselled about the available data before any treatment: the risk of transmitted chromosomal aberrations, the risk of de-novo, mainly sex chromosomal, aberrations and the risk of transmitting fertility problems to the offspring. Patients should also be reassured that there seems to be no higher incidence of congenital malformations in children born after ICSI.
The effect of elevated serum progesterone concentrations (> 1 ng/l) on or before the day of human chorionic gonadotrophin (HCG) injection on the outcome of women receiving gonadotrophin-releasing hormone analogue (GnRHa)/human menopausal gonadotrophin (HMG) for ovarian stimulation prior to intracytoplasmic sperm injection (ICSI) was evaluated. A total of 1275 ICSI cycles were analysed retrospectively. In 53 cycles (4.5%), serum progesterone concentrations were > 1 ng/ml. Patients in the high progesterone group had significantly higher oestradiol and luteinizing hormone concentrations on the day of HCG injection. The characteristics of the cumulus-corona cell complexes and the nuclear maturity of the oocytes were similar in the groups of patients with high and low serum progesterone levels. Fertilization and cleavage rates as well as embryo quality were not different in the two groups. No difference in implantation or clinical pregnancy rates was observed between the high progesterone and low progesterone groups. Moreover, the cumulative exposure to progesterone during the follicular phase, as expressed by the area under the curve (AUC), and the duration of exposure to high serum progesterone levels (> 1 ng/ml) were not significantly different between pregnant and non-pregnant women in the high progesterone group. We conclude that in ICSI cycles pretreated with GnRHa, increased serum progesterone concentrations on or before the day of HCG injection do not affect ICSI outcome.
Antisperm antibodies present in the semen can be a primary cause of infertility. If the proportion of spermatozoa carrying antisperm antibodies is very high, then usually a poor result ensues in standard in-vitro fertilization. We therefore employed intracytoplasmic sperm injection (ICSI) in 55 cycles (37 patients) where the proportion of antisperm antibody-bound spermatozoa was 80% or higher, as determined by the mixed antiglobulin reaction (MAR) test. The type and location of antisperm antibodies were determined by the immunobead test in 30 of the 37 patients. The mean normal fertilization rate was 75.7% in these 55 cycles, which was significantly higher than the fertilization rate in another 1767 ICSI cycles (69.2%) performed over the same period and where MAR-negative semen (the level of antisperm antibodies was < 80%) was used for microinjection. Embryonic development was comparable, but a higher proportion of poor-quality embryos was obtained with MAR-positive than with MAR-negative semen samples. Out of the 55 patients, 53 had embryos replaced (96.4%) and a fetal sac was detected by ultrasonography in 14 patients (26.4%). The data indicate that fertilization, embryo development and pregnancy rates after ICSI are not influenced significantly by the proportion of antisperm antibody-bound spermatozoa, nor by the dominant type of antibodies present, nor by the location of the antisperm antibody on the spermatozoa. The conclusion of this study is that ICSI should be the primary choice for patients who have high numbers of antisperm antibodies present in their semen.
In 1673 treatment cycles stimulated with buserelin and HMG, for IVF, GIFT or ZIFT, the severe ovarian hyperstimulation syndrome (OHSS) occurred in 10 cycles (0.6%). Eight patients were hyperandrogenic and showed an increased ovarian response to HMG. After replacement of a maximum of three embryos or zygotes, seven women became pregnant. Three women had a multiple gestation. All patients recovered uneventfully with conservative treatment. Support with progesterone or continuation of the agonist during the luteal phase did not prevent OHSS, confirming that the ovulatory HCG dose is the most important factor in inducing this severe complication. Luteal supplementation with HCG and/or HCG production during implantation could exacerbate OHSS.
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