International Standard Randomised Controlled Trial Number Register: Software Free Download8/15/2017 Research Prevention of multiple pregnancies in couples with unexplained or mild male subfertility: randomised controlled trial of in vitro fertilisation with single. Optical coherence tomography (OCT) is a newer intravascular imaging method than IVUS that provides rapid acquisition of higher resolution (10–20 ACCORD was a randomized trial conducted at 77 clinical sites organized into seven networks in the United States and Canada (for a full list of. Prevention of multiple pregnancies in couples with unexplained or mild male subfertility: randomised controlled trial of in vitro fertilisation with single embryo transfer or in vitro fertilisation in modified natural cycle compared with intrauterine ins. Secondary outcomes were live birth, clinical pregnancy, ongoing pregnancy, multiple pregnancy, time to pregnancy, complications of pregnancy, and neonatal morbidity and mortality. Results 6. 02 couples were randomly assigned between January 2. February 2. 01. 2; 2. Birth of a healthy child occurred in 1. This corresponds to a risk, relative to intrauterine insemination with ovarian hyperstimulation, of 1. These 9. 5% confidence intervals do not extend below the predefined threshold of 0. Multiple pregnancy rates per ongoing pregnancy were 6% (7/1. P=0. 5. 2 for in vitro fertilisation with single embryo transfer compared with intrauterine insemination with ovarian hyperstimulation; one sided P=0. Conclusions In vitro fertilisation with single embryo transfer and in vitro fertilisation in a modified natural cycle were non- inferior to intrauterine insemination with controlled ovarian hyperstimulation in terms of the birth of a healthy child and showed comparable, low multiple pregnancy rates.
![]() Trial registration Current Controlled Trials ISRCTN5. Nederlands Trial Register NTR9. Introduction. Involuntary childlessness affects more than 7. Most couples will seek fertility care and consult their general practitioner for guidance. Approximately half of these couples will be diagnosed as having unexplained or mild male subfertility. Most of them still have a good chance of conceiving and will achieve pregnancy without treatment. Treatment is thus indicated only if the chances of conceiving naturally are low and the success rate after treatment exceeds this probability. Intrauterine insemination with controlled ovarian hyperstimulation is the first line fertility treatment in couples with an unfavourable prognosis for natural conception. However, concern exists about the increased rates of multiple pregnancy after intrauterine insemination with controlled ovarian hyperstimulation, as a result of the stimulation of multiple follicles. Intrauterine insemination with controlled ovarian hyperstimulation results in pregnancy rates of 1. Multiple pregnancies are associated with maternal morbidity such as pre- eclampsia, gestational diabetes, and a 5. In vitro fertilisation with single embryo transfer is increasingly implemented and might be equally effective but safer, as it prevents multiple pregnancies. Live birth rates with the transfer of one good quality embryo are 2. The downside of in vitro fertilisation is that it is an invasive and burdensome procedure with higher costs. In vitro fertilisation in a modified natural cycle—a cycle in which monofollicular growth results in one oocyte at follicular aspiration and in one embryo after fertilisation—might be another treatment option. In vitro fertilisation with unstimulated or mildly stimulated regimens are becoming more popular. Cumulative live birth rates over six cycles of more than 3. In vitro fertilisation in a modified natural cycle has been advocated as less burdensome and less costly than “conventional” in vitro fertilisation. Multiple pregnancies seem to be prevented by in vitro fertilisation with single embryo transfer and in vitro fertilisation in a modified natural cycle, but this will be acceptable only if these interventions are as effective as intrauterine insemination with controlled ovarian hyperstimulation in terms of live birth rates. We therefore designed a randomised trial to evaluate the effectiveness of these interventions in terms of healthy children born from singleton pregnancies. Methods. We did a multicentre, open label, three arm, parallel group, randomised controlled non- inferiority trial in 1. Netherlands between January 2. February 2. 01. 3. Full details of the trial protocol can be found at www. Participants. Couples seeking fertility treatment after at least 1. All participating couples provided written informed consent. All couples underwent basic fertility investigations, which included semen analysis, evaluation of ovulation, and tubal patency testing (Chlamydia antibody test, hysterosalpingography or laparoscopy). Inclusion criteria were age of female partner between 1. We classified couples as having unexplained subfertility when the fertility investigations showed at least one patent fallopian tube, an ovulatory menstrual cycle, and a normal semen analysis (pre- wash total motile sperm count above 1. We considered couples who qualified for intrauterine insemination with donor sperm after at least six cycles of artificial intracervical insemination with donor sperm to have unexplained subfertility for the purpose of this study. Mild male subfertility was diagnosed when the semen analysis showed a pre- wash total motile sperm count between three and 1. Dutch guidelines). We defined an unfavourable prognosis for natural conception as a probability of natural conception within the next 1. Hunault. 7 This model encompasses female age, duration of subfertility, whether subfertility is primary or secondary, percentage of motile progressive sperm, and referral status. It is readily available for all clinicians (www. Exclusion criteria were anovulation, double sided tubal disease, severe endometriosis, premature ovarian failure, and known endocrine disorders (such as Cushing’s syndrome or adrenal hyperplasia). Randomisation and masking. Couples were randomly allocated in a 1: 1: 1 ratio to receive either three consecutive cycles of in vitro fertilisation with single embryo transfer plus subsequent cryocycles, six consecutive cycles of in vitro fertilisation in a modified natural cycle, or six consecutive cycles of intrauterine insemination with controlled ovarian hyperstimulation within 1. Randomisation was performed with an online randomisation program, using biased coin minimisation, stratified for study centre. A web based program generated a unique number with allocation code after entry of the patient’s initials and date of birth. Neither the recruiters nor the trial project group could access the randomisation sequence. Blinding was not possible owing to the nature of the interventions. Interventions. In the in vitro fertilisation with single embryo transfer group, participating hospitals could adhere to local stimulation protocols, which were either long/short agonist or antagonist protocols. Controlled ovarian hyperstimulation started with 1. IU follicle stimulating hormone. Treatment was continued until at least two follicles of at least 1. Ovulation triggering was induced by 1. IU human chorionic gonadotropin hormone (Pregnyl, Merck Sharp & Dohme), and cumulus- oocyte complexes were recovered by transvaginal ultrasound guided retrieval 3. We adhered to an elective single embryo transfer policy: if one good quality embryo was available, we transferred one embryo. If more than one good quality embryo was available, suitable surplus embryos were cryopreserved. If no good quality embryos were available, two embryos would be transferred. For the morphological score, the degree of fragmentation of the embryo and the uniformity of the blastomeres were assessed daily. The embryo was given a score of 1 (no fragmentation), 2 (< 2. We defined good quality embryos as those with a cumulative embryo score of 2. Embryo transfer followed on day three. All available frozen embryos were transferred after thawing before a new treatment cycle was started. During our trial, the results of a pilot study, randomising women to three cycles of intrauterine insemination with controlled ovarian hyperstimulation or one cycle of in vitro fertilisation with single embryo transfer, was published. This pilot study showed that the policy of transferring two embryos when no good quality embryos are available is not effective in preventing multiple pregnancies. We amended our study protocol, and from February 2. In the in vitro fertilisation in a modified natural cycle group, women were monitored by transvaginal ultrasound from days eight to 1. IU follicle stimulating hormone to prevent collapse of the follicle and a concomitant fall in oestradiol concentrations. Follicle stimulating hormone was continued up to the day of the ovulation triggering, and the gonadotropin releasing hormone antagonist was last given on the day of ovulation triggering. When a follicle with a diameter of 1. IU of human chorionic gonadotropin. Oocyte retrieval was planned 3. If an oocyte was obtained and fertilised, the embryo was transferred on day three. For luteal support, human chorionic gonadotropin 1. IU was given by subcutaneous injections on days five, eight, and 1. The next treatment cycle could start immediately after the previous cycle. In the intrauterine insemination with controlled ovarian hyperstimulation group, women received controlled ovarian hyperstimulation according to the local protocol, with either 1. IU follicle stimulating hormone (starting dose). Follicular growth was monitored by ultrasound; when at least one follicle of 1. IU human chorionic gonadotropin. Approximately 3. 6 hours thereafter, intrauterine insemination was performed. Intrauterine insemination with controlled ovarian hyperstimulation cycles were cancelled when there were more than three follicles with a diameter of 1. Those couples were instructed to refrain from unprotected intercourse. The box summarises the three interventions. The three interventions. Intrauterine insemination with controlled ovarian hyperstimulation. Hyperstimulation from cycle day 3 or 4; start with 1. IU FSHMonitoring of follicular growth by transvaginal ultrasound. Induction of final oocyte maturation with 5. IU of h. CG when . We included all interventions that couples received within 1. A pregnancy test was performed two weeks after embryo transfer or intrauterine insemination. Clinical and ongoing pregnancies were confirmed by ultrasonography.
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