In the decision, judges turned to what it called anti-abortion language in that state’s constitution and concluded that an 1872 state law that allows parents to sue over the death of a minor child “applies to all unborn children.”

“Unborn children are ‘children’ … without exception based on developmental stage, physical location, or any other ancillary characteristics,” Associate Justice Jay Mitchell wrote in the ruling.

Reaction to the decision was swift and strident, as infertility experts stressed the ruling ultimately threatens the use of IVF treatments.

“By insisting that these very different biological entities are legally equivalent, the best state-of-the-art fertility care will be made unavailable to the people of Alabama. No health care provider will be willing to provide treatments if those treatments may lead to civil or criminal charges,” Dr Paula Amato, president of the American Society for Reproductive Medicine, told the Associated Press.

“This ruling is stating that a fertilized egg, which is a clump of cells, is now a person. It really puts into question the practice of IVF,” Barbara Collura, CEO of RESOLVE: The National Infertility Association, told the AP.

The decision is a “terrifying development for the 1-in-6 people impacted by infertility” who need in-vitro fertilization, she said.

Following the ruling, it isn’t clear whether future embryos created during fertility treatments can be frozen or if patients could ever donate or destroy unused embryos.

But Sean Tipton, a spokesman with the American Society for Reproductive Medicine, told the AP that at least one Alabama fertility clinic has been instructed by their affiliated hospital to pause IVF treatment for now.

The plaintiffs in the Alabama case had IVF treatments that created several embryos, some of which were implanted and led to healthy births, the AP reported. The couples paid to keep the unused embryos frozen in a storage facility, but a patient managed to wander into the area in 2020 and removed several embryos, dropping them on the floor and “killing them,” the ruling said.

The justices ruled that the wrongful death lawsuits brought by the couples could proceed, although the clinic and hospital named as defendants in the case could appeal.

Michael Upchurch, a lawyer for the fertility clinic in the lawsuit, the Center for Reproductive Medicine, told the AP they are “evaluating the consequences of the decision and have no further comment at this time.”

Meanwhile, an anti-abortion group applauded the decision.

“This ruling, which involved a wrongful-death claim brought by parents against a fertility clinic that negligently caused the death of their children, rightly acknowledged the humanity of unborn children created through in vitro fertilization [IVF] and is an important step towards applying equal protection for all,” Lila Rose, president and founder of Live Action said in a statement.

Justice Greg Cook, who filed the only full dissent to the ruling, said the 1872 law was being stretched from its original intent to cover frozen embryos.

“No court, anywhere in the country, has reached the conclusion the main opinion reaches,” he wrote, adding the ruling “almost certainly ends the creation of frozen embryos through in vitro fertilization [IVF] in Alabama.”

White House press secretary Karine Jean-Pierre said Tuesday that the Alabama decision was yet another consequence of the US Supreme Court overturning Roe v. Wade in June 2022, the AP reported.

“This president and this vice president will continue to fight to protect access to reproductive health care and call on Congress to restore the protections of Roe v. Wade in federal law for all women in every state,” Jean-Pierre told reporters.

More information

The World Health Organization has more on abortion.

SOURCE: Associated Press

HealthDay News — In pregnancies conceived with infertility treatment, delivery at 39 weeks provides the lowest perinatal risk vs risk at the subsequent week of gestation, according to a study published online August 11 in JAMA Network Open.

Ira Hamilton, MD, from University of Cincinnati College of Medicine, and colleagues sought to identify the gestational age at which the ongoing risks for stillbirth are optimally balanced with the risks for neonatal comorbidities and infant deaths in term singleton pregnancies conceived with infertility treatment. The analysis included birth and death data from the US National Center for Health Statistics (2014 through 2018; 178,448 singleton term pregnancies).

The researchers found that the risk of delivery in the subsequent week of gestation was lower than the risk of delivery at both 37 weeks (628 vs 1005 per 10,000 live births) and 38 weeks (483 vs 625 per 10,000 live births). However, compared with risk of delivery at 39 weeks (479 vs 599 per 10,000 live births), the risk of delivery in the subsequent week of gestation was significantly elevated. No significant differences in risk were seen for 40 weeks (639 vs 594 per 10,000 live births) and 41 weeks (701 vs 633 per 10,000 live births).

“The findings suggest an increased risk of adverse perinatal outcomes with both early-term and late-term delivery among patients who conceived with infertility treatment,” the authors write.

Abstract/Full Text

The PherDal Kit has been cleared by the Food and Drug Administration (FDA) for over-the-counter home use by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal.

The kit includes 3 sets of sterile, single-use plastic syringes, semen collection cups, and Instructions for Use. The sterile syringe is designed to deploy the semen intravaginally. The PherDal Kit should be used during the ovulatory phase of the menstrual cycle.

The FDA clearance was based on data from a self-selection study that assessed whether users could accurately determine if they should use the product based on the box label. The study included 47 contraindicated female participants and 40 non-contraindicated female participants. Findings showed 98.9% (86/87) were able to successfully determine whether they should use the PherDal Kit. Among participants with low health literacy (n=34), 97% were able to correctly identify if the product was intended for them or not.

Additionally, findings from a labeling comprehension study, which included 164 biological female participants, showed that at least 90% were able to understand the box label and Instructions for Use and answer the label comprehension questions correctly. 

In a human sperm survival assay (HSSA), the PherDal syringe and collection cup were found not to be toxic to sperm, meeting the HSSA acceptance specification (≥80% of control motility at 24 hours) at all time points assessed.

“Our singular focus in pursuing FDA clearance was to make the PherDal Kit available to every person who is struggling to conceive,” said PherDal Founder and CEO Dr Jennifer Hintzsche, PhD. “Our mission now is to provide access to a sterile, safe, at-home fertility option backed by science – for anyone struggling to conceive, single parents by choice and members of the LGBTQIA+ community.”

The Company is now accepting pre-orders of the PherDal Kit. The first kits are expected to ship by the end of February 2024. The PherDal Kit costs $199.

HealthDay News — Adherence to the American Heart Association (AHA) diet is inversely associated with clinical pregnancy loss in women achieving pregnancy during the course of infertility treatment, according to a study published online August 18 in JAMA Network Open.

Albert Salas-Huetos, PhD, from Harvard T.H. Chan School of Public Health in Boston, and colleagues examined whether women’s adherence to an a priori-defined dietary pattern promoted for prevention of chronic conditions is associated with infertility treatment outcomes in a prospective cohort study. A total of 612 women undergoing infertility treatment cycles, including intrauterine insemination cycles and in vitro fertilization with or without intracytoplasmic sperm injection, were included.

The researchers observed no association between adherence to the 8 a priori dietary patterns with probability of clinical pregnancy or live birth following in vitro fertilization or intrauterine insemination. Adherence to the AHA dietary pattern was inversely associated with risks for total and clinical pregnancy loss. The adjusted probabilities of pregnancy loss in the lowest and highest quartile of the AHA dietary pattern were 0.41 and 0.28, respectively, among women who became pregnant during the course of infertility treatment. The corresponding adjusted probabilities were 0.30 and 0.15 for clinical pregnancy loss. For all other dietary patterns, except for the plant-based diet pattern, a similar pattern was observed.

“Our findings provide useful information that can be used in the design of future studies aimed at testing the effects of nutritional interventions on human fertility,” the authors write.

Abstract/Full Text

Editorial

HealthDay News — There are no differences in school-age childhood developmental and educational outcomes between in vitro fertilization (IVF) and spontaneously conceived children, according to a study published online January 24 in PLOS Medicine.

Amber L. Kennedy, MD, from the University of Melbourne in Australia, and colleagues examined the causal effect of IVF conception on primary school-age childhood developmental and educational outcomes vs outcomes associated with spontaneous conception. Analysis included 412,713 children born between 2005 and 2014.

The researchers observed no causal effect of IVF conception on the risk for developmental vulnerability at school entry compared with spontaneous conception (measured using Australian Early Developmental Census metrics at ages 4 to 6 years; adjusted risk ratio, 0.97; 95% CI, 0.77 to 1.25). Similarly, at age 7 to 9 years, there was no causal effect of IVF conception on the National Assessment Program-Literacy and Numeracy overall z score (adjusted mean difference, 0.030; 95% CI, −0.018 to 0.077) compared with spontaneous conception. Sex at birth, age at assessment, language background other than English, socioeconomic status, maternal age, parity, and education were all adjusted for the models.

“These findings provide reassurance for current and prospective parents, as well as clinicians who are involved in IVF,” the authors write.

Several authors disclosed financial ties to IVF companies.

Abstract/Full Text

HealthDay News — For women with multiple sclerosis (MS), there is no increased relapse rate after fertility treatment (FT), according to a study published online March 15 in Neurology, Neuroimmunology & Neuroinflammation.

Edith L. Graham, MD, from Northwestern University in Chicago, and colleagues examined the annualized relapse rate (ARR) 12 months pre-FT and 3 months post-FT in a multicenter cohort composed of patients with clinically isolated syndrome or MS aged 18 to 45 years (nine and 56 patients, respectively). Controlled ovarian stimulation followed by fresh embryo transfer (COS-ET), COS alone, embryo transfer (ET) alone, and oral ovulation induction (OI) were included as FTs of interest.

Data were included for 124 FT cycles: 61 COS-ET, 19 COS alone, 30 ET alone, and 14 OI. The researchers found that within three months of treatment, only five relapses occurred among four unique patients across 80 cycles with COS. There was no difference observed in mean ARR after versus before COS; no significant difference was seen in the incidence rate ratio. Three-month relapse was not reported in any cycles with therapeutic disease-modifying therapies during COS. There was no variation noted in relapse rates based on COS protocol. The ARR decreased from 0.26 to 0.09 within the first trimester of pregnancy among COS-ET cycles that achieved pregnancy. No relapses were reported within three months of ET alone, while one relapse occurred after OI.

“We hope our findings provide reassurance to those with MS as well as fertility experts that these treatments are not associated with elevated risks of relapses,” Graham said in a statement.

Several authors disclosed financial ties to the pharmaceutical industry.

Abstract/Full Text (subscription or payment may be required)

(HealthDay News) — There is a small increased risk for congenital genitourinary abnormalities after assisted reproductive technologies (ARTs), according to a study published online Oct 10 in the Annals of Internal Medicine.

Christos Venetis, MD, PhD, from the University of New South Wales in Sydney, and colleagues examined the role of underlying infertility and fertility treatment on congenital anomaly risks in the first 2 years of life in a propensity score-weighted population-based cohort study. Data were included for 851,984 infants (828,099 singletons and 23,885 plural children) delivered between 2009 and 2017.

The researchers found that the overall incidence of congenital anomalies was 459 and 757 per 10,000 singleton and plural births, respectively. ART-conceived singleton infants had an elevated risk for major genitourinary abnormalities compared with naturally conceived (NC) singleton control infants without a parental history of infertility (adjusted risk difference [aRD], 19.0 cases per 10,000 births); the risk was unchanged compared with NC singleton control infants with a parental history of infertility (aRD, 22 cases per 10,000 births).

In couples without male infertility, intracytoplasmic sperm injection (ICSI) was associated with an increased risk for major genitourinary abnormalities (aRD, 47.8 cases per 10,000 singleton births), after accounting for parental infertility. Some suggestion of an increased risk for congenital anomalies was seen after fresh embryo transfer, although the estimates were imprecise and inconsistent.

“We caution against overuse of ICSI without clear medical indications given its independent association with certain types of congenital anomalies,” the authors write. “The obstetric care of patients having conceived after ART should include perinatal screening before and after birth given the increased risks for certain congenital anomalies in offspring.”

Abstract/Full Text (subscription or payment may be required)